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NCT04347837
Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
NA trial testing Titan SGS stapler in Surgery in 62 participants. Completed in 16 December 2020.
16 December 2020
Quick facts
| Lead sponsor | Standard Bariatrics |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 2 July 2020 |
| Primary completion | 16 December 2020 |
| Estimated completion | 16 December 2020 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Titan SGS stapler
Conditions studied
- Surgery — all drugs for Surgery →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04347837
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Standard Bariatrics trials
Trials by the same sponsor.
- NCT04086433 — Gastric Tissue Stapler Comparison Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04347837 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 22 March 2021
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