At a glance
ClinicalIndex Comparison RecordN/ACompleted· 288 enrolled
Drug / intervention
Spatz3 Adjustable Balloondevice
Likely dose
Spatz3 Adjustable Balloon System—balloon volume adjustable as needed during implant periodAI-extracted
Key inclusion· 6
- ✓Age 22 to 65 years
- ✓BMI ≥30 and <40
- ✓History of obesity (BMI ≥30) for at least 2 years
- ✓Prior failure with non-surgical weight loss methods
Key exclusion· 34
- ✕Prior gastrointestinal surgery with sequelae such as obstruction, adhesive peritonitis, or known abdominal adhesions
- ✕Prior bariatric surgery (open or laparoscopic)
- ✕Prior surgery on esophagus, stomach, or hiatal hernia repair
- ✕Inflammatory GI disease including esophagitis, Barrett's esophagus, gastric or duodenal ulceration, Crohn's disease, or GI cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Multicenter Study Comparing the Spatz3 Adjustable Balloon System Plus Diet and Exercise to Diet and Exercise Alone
In Brief
A clinical study evaluating Spatz3 Adjustable Balloon for Obesity. Completed, enrolled 288 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a non-surgical device, is effective in the treatment of obesity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartSep 2016
Primary CompletionOct 2018
Study CompletionJan 2019
TodayJul 2026
First PostedJun 24, 2016
Enrollment StartSep 12, 2016
Primary CompletionOct 1, 2018
Study CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.0 years ago
Interventions
Spatz3 Adjustable Balloondevice
An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed