CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 276 enrolled
Drug / intervention
Swedish Adjustable Gastric Banddevice
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age 18–60 years
  • ✓BMI >40 kg/m² and <55 kg/m², OR BMI >35–40 kg/m² with ≥1 obesity-related comorbidity (diabetes, hyperlipidemia, sleep apnea, hypertension, metabolic syndrome, or knee/hip osteoarthritis)
  • ✓Five-year history of morbid obesity
  • ✓At least 100 lbs overweight or 1.5× ideal body weight
Key exclusion· 18
  • ✕Previous bariatric/restrictive surgery for obesity
  • ✕Drug and/or alcohol abuse within 2 years of screening
  • ✕Active mental health conditions: uncontrolled depression, suicidal attempts/ideation in past 2 years, schizophrenia, borderline personality disorder, or active substance abuse
  • ✕Active GI inflammatory disease (Crohn's, severe esophagitis, gastric/duodenal ulceration within 10 years)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00166205
NCT00166205Phase 3Completed
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A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

Ethicon Endo-Surgery·interventional·Posted Sep 14, 2005·Updated Sep 1, 2015

In Brief

A Phase 3 clinical trial evaluating Swedish Adjustable Gastric Band for Obesity, Morbid. Completed, enrolled 276 participants across 12 sites.

Detailed Summary

The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB) is safe, and effective in achieving weight loss in patients with Morbid Obesity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Morbid
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartJun 1, 2003
Study CompletionDec 1, 2006
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Swedish Adjustable Gastric Banddevice

Long term implantable device.