Who is sponsoring NCT04086433?

NCT04086433 is sponsored by Standard Bariatrics.

What drugs are being tested in NCT04086433?

Interventions in NCT04086433: gastric tissue resection.

What condition does NCT04086433 study?

NCT04086433 studies Gastric Resection.

Is NCT04086433 still recruiting?

NCT04086433 is currently completed. Last updated 25 June 2020.

Are results published for NCT04086433?

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

Last reviewed 2020-06-25 · How we verify

NCT04086433

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

Gastric Tissue Stapler Comparison Study

Completed Results posted Last updated 25 June 2020

What this trial tests

trial testing gastric tissue resection in Gastric Resection in 36 participants. Completed in 30 October 2019.

Timeline

15 July 2019

Primary endpoint
30 October 2019

30 October 2019

Quick facts

Lead sponsor	Standard Bariatrics
Status	Completed
Study type	OBSERVATIONAL
Enrollment	36
Start date	15 July 2019
Primary completion	30 October 2019
Estimated completion	30 October 2019
Sites	1 location across United States

Drugs / interventions tested

gastric tissue resection

Conditions studied

Gastric Resection — all drugs for Gastric Resection →

Sponsor

Standard Bariatrics

Who can join

Adults 18 to 80, any sex, with Gastric Resection. 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.

Pressure Evaluation Primary · immediately post operative

Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.

Group	Value	95% CI
Arm A - Echelon Stapler	126	46 – 226
Arm B - Titan Stapler	163	82 – 259

Adverse events — posted to ClinicalTrials.gov

Time frame: Not applicable. Investigation performed on excised tissue.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A - Echelon Stapler

Serious: 0

Deaths: 0

Arm B - Titan Stapler

Serious: 0

Deaths: 0

Other adverse events (1 terms — click to expand)

Reaction	System	Arm A - Echelon Stapler	Arm B - Titan Stapler
Other	Product Issues	—	—

Data from ClinicalTrials.gov NCT04086433 adverse events section.

Sponsor's own description

This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan"). The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.

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 recruiting trials for Gastric Resection

Currently open trials in the same condition.

NCT06028737 — Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer · Phase 2, PHASE3 · recruiting

Other Standard Bariatrics trials

Trials by the same sponsor.

NCT04347837 — Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection · 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 NCT04086433 (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 Standard Bariatrics
Last refreshed: 25 June 2020

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/NCT04086433.

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