Trial Outcomes & Findings for ReShape Intragastric Balloon for the Treatment of Obesity (NCT NCT01024465)
NCT ID: NCT01024465
Last Updated: 2015-09-29
Results Overview
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
baseline to 180 days
Results posted on
2015-09-29
Participant Flow
Participant milestones
| Measure |
ReShape Duo Balloon
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
ReShape Duo Balloon
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
ReShape Intragastric Balloon for the Treatment of Obesity
Baseline characteristics by cohort
| Measure |
ReShape Duo Balloon
n=26 Participants
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon
|
|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 11.2 • n=113 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: baseline to 180 daysPopulation: Subjects with a weight recorded at 6 months
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Outcome measures
| Measure |
ReShape Duo Balloon
n=22 Participants
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon
|
|---|---|
|
Total Weight Loss
|
-9.4 kg
Standard Deviation 6.3
|
Adverse Events
ReShape Duo Balloon
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ReShape Duo Balloon
n=26 participants at risk
Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon
ReShape Duo Balloon: ReShape Duo Balloon
|
|---|---|
|
Gastrointestinal disorders
nausea/vomiting after discharge
|
15.4%
4/26 • 180 days
|
|
Gastrointestinal disorders
gastric bloating
|
15.4%
4/26 • 180 days
|
|
Gastrointestinal disorders
epigastric pain
|
11.5%
3/26 • 180 days
|
|
Gastrointestinal disorders
GERD
|
11.5%
3/26 • 180 days
|
|
Gastrointestinal disorders
ulcer at removal
|
11.5%
3/26 • 180 days
|
|
Gastrointestinal disorders
diarrhea
|
7.7%
2/26 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Upon study conclusion, the PI has the right to use the study data for educational purposes, scientific conferences and publications. The sponsor will have a period of 15 days (for abstracts) and 30 days (for scientific publications) to review the proposal for disclosure / publication for the sole purpose of protecting any confidential information. If such disclosure contains Confidential Information, the PI agrees to remove such Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER