Trial Outcomes & Findings for A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects (NCT NCT01673698)
NCT ID: NCT01673698
Last Updated: 2015-12-07
Results Overview
An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
326 participants
Primary outcome timeframe
Week 24
Results posted on
2015-12-07
Participant Flow
Participant milestones
| Measure |
ReShape Duo Balloon
ReShape Duo Balloon
ReShape Duo balloon
Diet counseling
Exercise counseling
|
Sham Comparator
Sham Comparator
Diet counseling
Exercise counseling
|
|---|---|---|
|
Overall Study
STARTED
|
187
|
139
|
|
Overall Study
COMPLETED
|
136
|
126
|
|
Overall Study
NOT COMPLETED
|
51
|
13
|
Reasons for withdrawal
| Measure |
ReShape Duo Balloon
ReShape Duo Balloon
ReShape Duo balloon
Diet counseling
Exercise counseling
|
Sham Comparator
Sham Comparator
Diet counseling
Exercise counseling
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
51
|
13
|
Baseline Characteristics
A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
Baseline characteristics by cohort
| Measure |
ReShape Duo Balloon
n=187 Participants
ReShape Duo Balloon
ReShape Duo balloon
Diet counseling
Exercise counseling
|
Sham Comparator
n=139 Participants
Sham Comparator
Diet counseling
Exercise counseling
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.77 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
44.04 years
STANDARD_DEVIATION 10.17 • n=7 Participants
|
43.88 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
BMI
|
35.32 kg/m^2
STANDARD_DEVIATION 2.84 • n=5 Participants
|
35.43 kg/m^2
STANDARD_DEVIATION 2.63 • n=7 Participants
|
35.37 kg/m^2
STANDARD_DEVIATION 2.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.
Outcome measures
| Measure |
Treatment
n=187 Participants
Treatment group
|
Control
n=139 Participants
Control group
|
|---|---|---|
|
Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24
|
25.1 percentage of EWL
Standard Error 1.596
|
11.3 percentage of EWL
Standard Error 1.881
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.
An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of \>25% EWL at 24 weeks was significantly greater than 35%.
Outcome measures
| Measure |
Treatment
n=187 Participants
Treatment group
|
Control
Control group
|
|---|---|---|
|
Treatment Group Responder Rate Dichotomized at 25% EWL
|
48.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.
Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.
Outcome measures
| Measure |
Treatment
n=156 Participants
Treatment group
|
Control
Control group
|
|---|---|---|
|
Weight Loss Maintenance Six Months Following Device Removal
|
49.4 percentage of participant
|
—
|
Adverse Events
Treatment Subjects
Serious events: 25 serious events
Other events: 186 other events
Deaths: 0 deaths
Control Subjects
Serious events: 6 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Subjects
n=187 participants at risk
Subjects who were randomized and received a balloon during weeks 0-24
|
Control Subjects
n=139 participants at risk
Subjects who were randomized to diet and exercise counseling only during weeks 0-24
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/187 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/187 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/187 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/187 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
|
Nervous system disorders
Hypersensitivity
|
0.00%
0/187 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Nervous system disorders
Migraine
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
11/187 • Number of events 11 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
8/187 • Number of events 8 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
2/187 • Number of events 2 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Pelvic pain
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal hemmorhage
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Fecaloma
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Infections and infestations
Pneumonia
|
0.53%
1/187 • Number of events 1 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/187 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
Other adverse events
| Measure |
Treatment Subjects
n=187 participants at risk
Subjects who were randomized and received a balloon during weeks 0-24
|
Control Subjects
n=139 participants at risk
Subjects who were randomized to diet and exercise counseling only during weeks 0-24
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
88.2%
165/187 • Number of events 196 • 24 Weeks
|
5.0%
7/139 • Number of events 7 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
55.6%
104/187 • Number of events 134 • 24 Weeks
|
20.1%
28/139 • Number of events 31 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
58.8%
110/187 • Number of events 124 • 24 Weeks
|
20.1%
28/139 • Number of events 33 • 24 Weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
38.5%
72/187 • Number of events 73 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Gastrointestinal disorders
Eructation
|
16.6%
31/187 • Number of events 34 • 24 Weeks
|
4.3%
6/139 • Number of events 6 • 24 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
15.0%
28/187 • Number of events 32 • 24 Weeks
|
0.72%
1/139 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.9%
26/187 • Number of events 29 • 24 Weeks
|
3.6%
5/139 • Number of events 5 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.8%
24/187 • Number of events 29 • 24 Weeks
|
5.0%
7/139 • Number of events 7 • 24 Weeks
|
|
Gastrointestinal disorders
Constipation
|
13.9%
26/187 • Number of events 27 • 24 Weeks
|
7.9%
11/139 • Number of events 11 • 24 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
10.7%
20/187 • Number of events 21 • 24 Weeks
|
4.3%
6/139 • Number of events 6 • 24 Weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.6%
18/187 • Number of events 20 • 24 Weeks
|
2.2%
3/139 • Number of events 3 • 24 Weeks
|
|
Gastrointestinal disorders
Gastritis erosive
|
9.1%
17/187 • Number of events 17 • 24 Weeks
|
0.00%
0/139 • 24 Weeks
|
|
Infections and infestations
Influenza
|
3.7%
7/187 • Number of events 7 • 24 Weeks
|
5.0%
7/139 • Number of events 7 • 24 Weeks
|
|
Infections and infestations
Sinusitis
|
3.2%
6/187 • Number of events 6 • 24 Weeks
|
5.0%
7/139 • Number of events 7 • 24 Weeks
|
|
Infections and infestations
Gastroenteritis viral
|
2.7%
5/187 • Number of events 5 • 24 Weeks
|
5.0%
7/139 • Number of events 7 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.8%
24/187 • Number of events 26 • 24 Weeks
|
3.6%
5/139 • Number of events 5 • 24 Weeks
|
|
Nervous system disorders
Headache
|
5.3%
10/187 • Number of events 10 • 24 Weeks
|
6.5%
9/139 • Number of events 9 • 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After 12 months after the clinical study report is available, the PI may publish clinical study results, subject to confidentiality agreements and sponsor approval. The PI shall provide sponsor a copy of proposed publication at least 60 days prior to submission so that sponsor may have the opportunity to protect its proprietary rights to information, inventions, or products developed under the clinical study. PI agrees to remove confidential information upon sponsor request.
- Publication restrictions are in place
Restriction type: OTHER