Clinical trial NCT05049824: Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.

Detailed description: Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Known or suspected allergy to nickel or titanium or nitinol
* Contraindication to general anesthesia
* 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.
* Clinically significant findings during screening endoscopy at target region for compression anastomosis
* Uncontrolled hypertension
* Pre-existing severe comorbid cardio-respiratory disease
* History of type 1 diabetes or poorly controlled type 2 diabetes
* Abnormal liver biochemistry
* History of chronic gastrointestinal disease
* Specific genetic or hormonal cause of obesity
* Recent tobacco/nicotine product cessation (within 3 months prior)

Primary outcomes:
measure: Weight Loss
timeFrame: 12 Months
Secondary outcomes:
measure: Percent responders
timeFrame: 12 Months
measure: Excess weight loss
timeFrame: 12 Months
measure: Change in serum lipids
timeFrame: 12 Months
measure: Change in blood pressure
timeFrame: 12 Months
measure: Change in fasting glucose
timeFrame: 12 Months
measure: Change in HbA1c
timeFrame: 12 Months
measure: Change in BMI
timeFrame: 12 Months
measure: Change in Absolute Weight Loss
timeFrame: 12 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon
Study officials:
affiliation: Gastroenterologist at Teknon Hospital
name: Roman Turro, MD
role: PRINCIPAL_INVESTIGATOR
References: