Who is sponsoring NCT04544865?

NCT04544865 is sponsored by Ethicon Endo-Surgery.

What drugs are being tested in NCT04544865?

Interventions in NCT04544865: Staple Line Reinforcement.

What condition does NCT04544865 study?

NCT04544865 studies Gastric Procedures, Lung Resection Procedures.

Is NCT04544865 still recruiting?

NCT04544865 is currently completed. Last updated 5 December 2023.

Are results published for NCT04544865?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-05 · How we verify

NCT04544865

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

Completed NA Results posted Last updated 5 December 2023

What this trial tests

NA trial testing Staple Line Reinforcement in Gastric Procedures in 240 participants. Completed in 8 February 2023.

Timeline

29 September 2020

Primary endpoint
17 October 2022

8 February 2023

Quick facts

Lead sponsor	Ethicon Endo-Surgery
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	29 September 2020
Primary completion	17 October 2022
Estimated completion	8 February 2023
Sites	8 locations across United States

Drugs / interventions tested

Staple Line Reinforcement

Conditions studied

Gastric Procedures — all drugs for Gastric Procedures →
Lung Resection Procedures — all drugs for Lung Resection Procedures →

Sponsor

Ethicon Endo-Surgery — full company profile →

Who can join

18 and older, any sex, with Gastric Procedures or Lung Resection Procedures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures Primary · From Day 0 (day of surgery) through 70 days post-surgery

Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of

Bleeding

Group	Value	95% CI
Gastric Participants	0

Leak

Group	Value	95% CI
Gastric Participants	1

Stricture

Group	Value	95% CI
Gastric Participants	0

Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days Primary · From Day 0 (day of surgery) through 70 days post-surgery

Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema).

Prolonged air leak

Group	Value	95% CI
Thoracic Participants	0

Empyema

Group	Value	95% CI
Thoracic Participants	0

Number of Study Devices Replaced During Surgery Secondary · Day 0 (Intra-surgery)

Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported.

Slipping

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	3

Bunching

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	1

Not Loaded Properly

Group	Value	95% CI
Gastric Participants	7
Thoracic Participants	3

Other - Preloaded Wrong Color Cartridge

Group	Value	95% CI
Gastric Participants	1
Thoracic Participants	0

Other- SLR Added Before Cartridge

Group	Value	95% CI
Gastric Participants	1
Thoracic Participants	0

Other- Dropped on the Ground

Group	Value	95% CI
Gastric Participants	1
Thoracic Participants	0

Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Secondary · Day 0 (Intra-surgery)

Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response

Experienced less buttress manipulation and movement compared to previous buttress: Strongly disagree

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	1

Experienced less buttress manipulation and movement compared to previous buttress: Slightly disagree

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	1

Experienced less buttress manipulation and movement compared to previous buttress: Neutral

Group	Value	95% CI
Gastric Participants	3
Thoracic Participants	1

Experienced less buttress manipulation and movement compared to previous buttress: Slightly agree

Group	Value	95% CI
Gastric Participants	6
Thoracic Participants	2

Experienced less buttress manipulation and movement compared to previous buttress: Strongly agree

Group	Value	95% CI
Gastric Participants	3
Thoracic Participants	13

Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly disagree

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Greater confidence that SLR buttress deliver best outcomes compared to previous:Slightly disagree

Group	Value	95% CI
Gastric Participants	3
Thoracic Participants	0

Greater confidence that SLR buttress deliver best outcomes compared to previous: Neutral

Group	Value	95% CI
Gastric Participants	6
Thoracic Participants	0

Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Secondary · Day 0 (Intra-surgery)

Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device" and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses

Satisfaction of operative flow compared to previous device: Very dissatisfied

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Satisfaction of operative flow compared to previous device: Dissatisfied

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Satisfaction of operative flow compared to previous device: Neither dissatisfied nor satisfied

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Satisfaction of operative flow compared to previous device: Satisfied

Group	Value	95% CI
Gastric Participants	3
Thoracic Participants	2

Satisfaction of operative flow compared to previous device: Very satisfied

Group	Value	95% CI
Gastric Participants	9
Thoracic Participants	16

Satisfaction of manipulation and repositioning compared to previous device:Very dissatisfied

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Satisfaction of manipulation and repositioning compared to previous device: Dissatisfied

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Satisfaction of manipulation and repositioning compared to previous device: NDNS

Group	Value	95% CI
Gastric Participants	0
Thoracic Participants	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 0 (Day of surgery) up to end of the study (2 years 4 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gastric Participants

Serious: 8/109 (7%)

Deaths: 0/109

Thoracic Participants

Serious: 18/131 (14%)

Deaths: 2/131

Serious adverse events (38 terms)

Reaction	System	Gastric Participants	Thoracic Participants
Pulmonary air leakage	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Atrial fibrillation	Cardiac disorders	—	—
Portal vein thrombosis	Hepatobiliary disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Haemothorax	Respiratory, thoracic and mediastinal disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Gastric Fistulas	Gastrointestinal disorders	—	—
Gastric perforation	Gastrointestinal disorders	—	—
Gastric ulcer	Gastrointestinal disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Intra-abdominal haemorrhage	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Bacteraemia	Infections and infestations	—	—
Fungaemia	Infections and infestations	—	—
Lung infection	Infections and infestations	—	—
Pneumonia viral	Infections and infestations	—	—
Postoperative wound infection	Infections and infestations	—	—
Cardiac failure acute	Cardiac disorders	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—

Other adverse events (168 terms — click to expand)

Reaction	System	Gastric Participants	Thoracic Participants
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Pulmonary air leakage	Respiratory, thoracic and mediastinal disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Dysphagia	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Incision site pain	Injury, poisoning and procedural complications	—	—
Chest pain	General disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Pneumonia	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Urinary retention	Renal and urinary disorders	—	—
Short-bowel syndrome	Gastrointestinal disorders	—	—
Hypophagia	Metabolism and nutrition disorders	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—
Hypotension	Vascular disorders	—	—
Haemothorax	Respiratory, thoracic and mediastinal disorders	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Eructation	Gastrointestinal disorders	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Haematochezia	Gastrointestinal disorders	—	—
Hiatus hernia	Gastrointestinal disorders	—	—

Most-reported serious reactions: Pulmonary air leakage, Respiratory failure, Nausea, Pneumonia, Atrial fibrillation, Portal vein thrombosis, Acute respiratory failure, Haemothorax.

Data from ClinicalTrials.gov NCT04544865 adverse events section.

Sponsor's own description

This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Ethicon Endo-Surgery trials

Trials by the same sponsor.

NCT06608485 — A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures · recruiting
NCT05519215 — A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures · completed
NCT05133141 — A Study of the ECHELON Contour Curved Cutter Stapler Device in Colorectal Procedures · terminated
NCT05067647 — A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (E · NA · completed
NCT05039021 — A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04544865 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ethicon Endo-Surgery
Last refreshed: 5 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04544865.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing