Trial Outcomes & Findings for The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects (NCT NCT01061385)
NCT ID: NCT01061385
Last Updated: 2016-05-13
Results Overview
the difference between the %EWL between treatment and control groups must be clinically significant
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
36 Weeks
Results posted on
2016-05-13
Participant Flow
Participant milestones
| Measure |
ReShape Intragastric Balloon
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control Arm
Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
9
|
|
Overall Study
COMPLETED
|
20
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
ReShape Intragastric Balloon
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control Arm
Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
subject decision not related to AE
|
0
|
1
|
Baseline Characteristics
The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects
Baseline characteristics by cohort
| Measure |
ReShape Intragastric Balloon
n=21 Participants
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control Arm
n=9 Participants
Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
n=5 Participants
|
45.3 years
n=7 Participants
|
40.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 Weeksthe difference between the %EWL between treatment and control groups must be clinically significant
Outcome measures
| Measure |
ReShape Intragastric Balloon
n=21 Participants
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control
n=9 Participants
Control subjects receiving diet and exercise counseling only
|
|---|---|---|
|
%Excess Weight Loss
|
20.2 percent excess weight loss
Standard Deviation 16.7
|
12.7 percent excess weight loss
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 12 monthsa between-group comparison of percentage of treatment subjects achieving \>=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving \>= 25%EWL at 12 months
Outcome measures
| Measure |
ReShape Intragastric Balloon
n=20 Participants
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control
n=8 Participants
Control subjects receiving diet and exercise counseling only
|
|---|---|---|
|
Percentage of Subjects With >=25% Excess Weight Loss (EWL)
|
30 percentage of subjects
|
25 percentage of subjects
|
Adverse Events
ReShape Intragastric Balloon
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ReShape Intragastric Balloon
n=21 participants at risk
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control Arm
n=9 participants at risk
Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Eye disorders
periorbital edema
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
Nausea and vomiting
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
Other adverse events
| Measure |
ReShape Intragastric Balloon
n=21 participants at risk
Patients receiving the ReShape Intragastric Balloon
ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks
|
Control Arm
n=9 participants at risk
Patients presenting for weight loss using behaviour modification (diet and exercise) alone.
Behavioral modification: Diet and exercise
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
100.0%
21/21 • Number of events 27 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
vomiting
|
85.7%
18/21 • Number of events 25 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
eructation
|
47.6%
10/21 • Number of events 11 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
abdominal pain upper
|
42.9%
9/21 • Number of events 10 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
42.9%
9/21 • Number of events 12 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
abdominal discomfort
|
38.1%
8/21 • Number of events 8 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
dyspepsia
|
33.3%
7/21 • Number of events 7 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
gastric dilatation
|
33.3%
7/21 • Number of events 8 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
diarrhea
|
28.6%
6/21 • Number of events 7 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
abdominal pain
|
14.3%
3/21 • Number of events 3 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Gastrointestinal disorders
constipation
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Infections and infestations
sinusitis
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
22.2%
2/9 • Number of events 2 • 48 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
9.5%
2/21 • Number of events 3 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Infections and infestations
urinary tract infection
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Infections and infestations
vaginal infection
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Metabolism and nutrition disorders
dehydration
|
23.8%
5/21 • Number of events 5 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
back pain
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
22.2%
2/9 • Number of events 2 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
ligament rupture
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
post-traumatic pain
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
headache
|
14.3%
3/21 • Number of events 3 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Nervous system disorders
migraine
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
anxiety
|
14.3%
3/21 • Number of events 3 • 48 weeks
|
0.00%
0/9 • 48 weeks
|
|
Reproductive system and breast disorders
vaginal haemorrhage
|
0.00%
0/21 • 48 weeks
|
11.1%
1/9 • Number of events 1 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall furnish a copy of any proposed publication or disclosure 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. If such publication or disclosure contains Confidential Information, the PI agrees to remove such Confidential Information upon the Sponsor's request.
- Publication restrictions are in place
Restriction type: OTHER