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NCT05064722
Duodenal-Ileal Diversion in Obese Patients Undergoing Primary Sleeve or Those With Inadequate Weight Loss After Sleeve
NA trial testing Self Forming Magnets (SFM) in Obesity, Morbid in 10 participants. Completed in 9 October 2024.
15 April 2024
Quick facts
| Lead sponsor | GI Windows, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 8 November 2021 |
| Primary completion | 15 April 2024 |
| Estimated completion | 9 October 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Self Forming Magnets (SFM)
Conditions studied
- Obesity, Morbid — all drugs for Obesity, Morbid →
Sponsor
GI Windows, Inc.
Who can join
Adults 22 to 65, any sex, with Obesity, Morbid. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a dual-path duodenal-ileal (D-I) diversion either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SNAP-S/SNAP-PS procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.
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:
- PubMed search for NCT05064722
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Obesity, Morbid
Currently open trials in the same condition.
- NCT07119437 — Low Impact Laparoscopy In Bariatric Surgery · NA · recruiting
- NCT05927519 — Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study · NA · recruiting
- NCT06530212 — Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass · NA · recruiting
- NCT06477120 — Time-restricted Eating Among Pregnant Females With Severe Obesity · NA · recruiting
- NCT06119516 — Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study. · NA · recruiting
Other GI Windows, Inc. trials
Trials by the same sponsor.
- NCT06454916 — Functional Lumen Opening With Self-Forming Magnetic Anastomosis · NA · completed
- NCT06199635 — Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) · NA · active not recruiting
- NCT06200896 — Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patie · NA · completed
- NCT05046730 — SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression · NA · terminated
- NCT05049824 — Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05064722 (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 GI Windows, Inc.
- Last refreshed: 15 October 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/NCT05064722.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing