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NCT04347837

Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection

Completed NA Last updated 22 March 2021
What this trial tests

NA trial testing Titan SGS stapler in Surgery in 62 participants. Completed in 16 December 2020.

Timeline
2 July 2020
Primary endpoint
16 December 2020
16 December 2020

Quick facts

Lead sponsorStandard Bariatrics
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment62
Start date2 July 2020
Primary completion16 December 2020
Estimated completion16 December 2020
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Standard Bariatrics

Who can join

Adults 18 to 65, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal resection of the stomach. This is the first experience using this stapler in humans. The purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal gastric resection. Safety is defined by the absence of device related adverse events in the study period. Usability is evaluated based on surgeon evaluation of the device following each use. This is a open label clinical trial to be conducted at three US sites. Up to 60 participants will be enrolled and will be followed for 6 weeks after surgery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Multisite study of Titan SGS stapler in longitudinal gastric resection.
    Salyer CE, Thompson J, Hoffman A, Burstein MD, et al · · 2022 · cited 2× · PMID 35080675 · DOI 10.1007/s00464-022-09051-x

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Other recruiting trials for Surgery

Currently open trials in the same condition.

Other Standard Bariatrics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04347837.

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