Phase 3
Completed N=50
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
Source: ClinicalTrials.gov NCT00580502 ↗Enrolled (actual)
50
Serious AEs
28.0%
Results posted
Mar 2015
Primary outcomePrimary: To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery — 51.74 percentage of excess weight loss
Summary
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery |
51.74 | — |
| SECONDARY Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery |
117 | — |
| SECONDARY Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery |
103 | — |
| SECONDARY Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery |
5.6 | — |
Eligibility Criteria
Inclusion Criteria
- Be at least 18 and equal to or less than 60 years of age.
- BMI of at least 30 and maximum BMI of 40 with co-morbidities
- Willingness to comply with dietary restrictions required by the protocol
- History of obesity for at least 5 years
- History of at least 6 months of documented failures with traditional non-surgical weight loss methods
- Willingness to follow protocol requirements
- If female with childbearing potential, using an appropriate form of contraception
Exclusion Criteria
- Age less than 18, age greater than 60
- Pregnancy
- History of major depressive disorder or psychosis
- Previous bariatric surgery or previous gastric surgery
- Presence of achalasia
- Presence of portal hypertension, cirrhosis, and/or varices
- Patient with inflammatory disease of the gastrointestinal tract such as Crohn's Disease
- Patients with autoimmune connective tissue disorders
- Patients with acute abdominal infections
- Any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study
Data sourced from ClinicalTrials.gov (NCT00580502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.