Who is sponsoring NCT04763421?

NCT04763421 is sponsored by Ethicon Endo-Surgery.

What drugs are being tested in NCT04763421?

Interventions in NCT04763421: ENSEAL X1 Curved Jaw.

What condition does NCT04763421 study?

NCT04763421 studies Upper GI; Lower GI; Gynecological.

Is NCT04763421 still recruiting?

NCT04763421 is currently completed. Last updated 24 September 2024.

Are results published for NCT04763421?

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

Last reviewed 2024-09-24 · How we verify

NCT04763421

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

A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures

Completed NA Results posted Last updated 24 September 2024

What this trial tests

NA trial testing ENSEAL X1 Curved Jaw in Upper GI; Lower GI; Gynecological in 145 participants. Completed in 29 September 2023.

Timeline

22 April 2021

Primary endpoint
30 August 2023

29 September 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	145
Start date	22 April 2021
Primary completion	30 August 2023
Estimated completion	29 September 2023
Sites	6 locations across Italy, United Kingdom, United States

Drugs / interventions tested

ENSEAL X1 Curved Jaw

Conditions studied

Upper GI; Lower GI; Gynecological — all drugs for Upper GI; Lower GI; Gynecological →

Sponsor

Ethicon Endo-Surgery — full company profile →

Who can join

18 and older, any sex, with Upper GI; Lower GI; Gynecological. 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 Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale Primary · On the day of transection (Day 0)

Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (examp

Group	Value	95% CI
ENSEAL X1 Curved Jaw	279

Number of Participants With Device-related Adverse Events (AEs) Primary · From Day 0 up to post-procedure follow up visit (up to 28 days)

Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices.

Group	Value	95% CI
ENSEAL X1 Curved Jaw	2

Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Secondary · On the day of transection (Day 0)

Number of participants with adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1.

Very Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Neither Satisfied or Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	1

Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	27

Very Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	21

Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Secondary · On the day of transection (Day 0)

Number of participants with lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1.

Very Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Neither Satisfied or Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	1

Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	18

Very Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	8

Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Secondary · On the day of transection (Day 0)

Number of participants with tissues bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1.

Very Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Neither Satisfied or Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	1

Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	26

Very Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	28

Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Secondary · On the day of transection (Day 0)

Number of participants with tissues grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1.

Very Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	4

Neither Satisfied or Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	9

Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	31

Very Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	23

Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Secondary · On the day of transection (Day 0)

Number of participants with tissues cutting using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1.

Very Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	1

Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	1

Neither Satisfied or Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	3

Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	38

Very Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	44

Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score Secondary · On the day of transection (Day 0)

Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1.

Very Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Neither Satisfied or Dissatisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	3

Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	59

Very Satisfied

Group	Value	95% CI
ENSEAL X1 Curved Jaw	45

Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale Secondary · On the day of transection (Day 0)

Number of vessels with hemostasis (Grade 1 to 4) based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (ex

Grade 1

Group	Value	95% CI
ENSEAL X1 Curved Jaw	258

Grade 2

Group	Value	95% CI
ENSEAL X1 Curved Jaw	12

Grade 3

Group	Value	95% CI
ENSEAL X1 Curved Jaw	9

Grade 4

Group	Value	95% CI
ENSEAL X1 Curved Jaw	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 0 up to post-procedure follow up visit (Up to 28 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ENSEAL X1 Curved Jaw

Serious: 10/145 (7%)

Deaths: 0/145

Serious adverse events (10 terms)

Reaction	System	ENSEAL X1 Curved Jaw
Abdominal pain	Gastrointestinal disorders	—
Ileus	Gastrointestinal disorders	—
Intra-abdominal haematoma	Gastrointestinal disorders	—
Cellulitis	Infections and infestations	—
Septic shock	Infections and infestations	—
Procedural pain	Injury, poisoning and procedural complications	—
Vaginal haemorrhage	Reproductive system and breast disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Lymphatic fistula	Vascular disorders	—
Pelvic venous thrombosis	Vascular disorders	—

Other adverse events (48 terms — click to expand)

Reaction	System	ENSEAL X1 Curved Jaw
Nausea	Gastrointestinal disorders	—
Pain	General disorders	—
Vomiting	Gastrointestinal disorders	—
Procedural pain	Injury, poisoning and procedural complications	—
Abdominal pain	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Ileus	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Incision site pain	Injury, poisoning and procedural complications	—
Dehydration	Metabolism and nutrition disorders	—
Dizziness	Nervous system disorders	—
Hallucination	Psychiatric disorders	—
Tachycardia	Cardiac disorders	—
Diarrhoea	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Lower respiratory tract infection	Infections and infestations	—
Wound complication	Injury, poisoning and procedural complications	—
Oxygen saturation decreased	Investigations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Confusional state	Psychiatric disorders	—
Hypotension	Vascular disorders	—
Atrial fibrillation	Cardiac disorders	—
Abdominal distension	Gastrointestinal disorders	—
Abdominal pain lower	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Intra-abdominal haemorrhage	Gastrointestinal disorders	—
Chest discomfort	General disorders	—
Chest pain	General disorders	—
Chills	General disorders	—
Injection site pruritus	General disorders	—
Cystitis	Infections and infestations	—
Oral candidiasis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Wound infection	Infections and infestations	—
Genital contusion	Injury, poisoning and procedural complications	—
Procedural nausea	Injury, poisoning and procedural complications	—
Haemoglobin decreased	Investigations	—
Decreased appetite	Metabolism and nutrition disorders	—

Most-reported serious reactions: Abdominal pain, Ileus, Intra-abdominal haematoma, Cellulitis, Septic shock, Procedural pain, Vaginal haemorrhage, Pneumothorax.

Data from ClinicalTrials.gov NCT04763421 adverse events section.

Sponsor's own description

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 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 NCT04763421 (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: 24 September 2024

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/NCT04763421.

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

NCT04763421

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Ethicon Endo-Surgery trials

Verify against primary sources