NCT05049824Completed
Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy
Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 9 Sept 2021
- Start date
- Oct 2021
- Primary completion date
- Jul 2023
- Lead sponsor
- GI Windows, Inc.
- Diseases
- Obesity
- NCT number
- NCT05049824
What you commit to
- Study type: Interventional
- Participants enrolled: 27
- From Oct 2021 to the primary completion date, Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series
- Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- Recent tobacco/nicotine product cessation (within 3 months prior)
Other illness
- Known or suspected allergy to nickel or titanium or nitinol
- Uncontrolled hypertension
- Pre-existing severe comorbid cardio-respiratory disease
- History of type 1 diabetes or poorly controlled type 2 diabetes
- History of chronic gastrointestinal disease
Other
- Contraindication to general anesthesia
- Clinically significant findings during screening endoscopy at target region for compression anastomosis
- Abnormal liver biochemistry
- Specific genetic or hormonal cause of obesity
Who the study is looking for
- Age 22-65 years at screening
- Body mass index (BMI) ≥35 and ≤50
- Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.
- Weight stable over 3-month period
- Negative H. pylori breath test
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
- If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
- Able to understand and sign informed consent documents.
Age in the registry: 19 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Médico Teknon Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.