Trial Outcomes & Findings for Multi-Center Pre-Bariatric Weight Loss Study (NCT NCT00469391)
NCT ID: NCT00469391
Last Updated: 2017-02-15
Results Overview
Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
3 months
Results posted on
2017-02-15
Participant Flow
Participant milestones
| Measure |
GI Sleeve
GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
|
Sham Control
Sham Procedure followed by standard-of-care diet therapy
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
|
Overall Study
Discontinued Prior to Procedure
|
2
|
3
|
|
Overall Study
Unsuccessful Implant Procedure
|
4
|
0
|
|
Overall Study
Adverse Event
|
8
|
0
|
|
Overall Study
Lost to Follow up
|
0
|
1
|
|
Overall Study
Patient Preference
|
0
|
1
|
|
Overall Study
COMPLETED
|
13
|
24
|
|
Overall Study
NOT COMPLETED
|
14
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Center Pre-Bariatric Weight Loss Study
Baseline characteristics by cohort
| Measure |
GI Sleeve
n=21 Participants
medical device that mimics gastric bypass mechanism for weight-loss
GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss
|
Sham Control
n=26 Participants
Sham Procedure: Weight loss
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Gender
Female
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsExcess Weight Loss was calculated using the Metropolitan Life Table (MET method)
Outcome measures
| Measure |
GI Sleeve
n=13 Participants
medical device that mimics gastric bypass mechanism for weight-loss
GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss
|
Sham Control
n=24 Participants
Sham Procedure: Weight loss
|
|---|---|---|
|
Percent Excess Weight Loss (%EWL) at Week 12
|
11.9 Percentage of Excess Weight Loss
Standard Deviation 1.4
|
2.7 Percentage of Excess Weight Loss
Standard Deviation 2.0
|
Adverse Events
GI Sleeve
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Sham Control
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GI Sleeve
n=21 participants at risk
N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
|
Sham Control
n=26 participants at risk
3 subjects withdrew before the procedure. N=26 for the ITT population.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
9.5%
2/21 • Number of events 2
|
0.00%
0/26
|
Other adverse events
| Measure |
GI Sleeve
n=21 participants at risk
N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
|
Sham Control
n=26 participants at risk
3 subjects withdrew before the procedure. N=26 for the ITT population.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
42.9%
9/21 • Number of events 9
|
11.5%
3/26 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
28.6%
6/21 • Number of events 6
|
19.2%
5/26 • Number of events 5
|
|
Injury, poisoning and procedural complications
Adverse drug reaction
|
4.8%
1/21 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21
|
11.5%
3/26 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • Number of events 2
|
0.00%
0/26
|
|
General disorders
Fatigue
|
14.3%
3/21 • Number of events 3
|
7.7%
2/26 • Number of events 2
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2
|
11.5%
3/26 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
23.8%
5/21 • Number of events 5
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/21
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
9.5%
2/21 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
76.2%
16/21 • Number of events 16
|
23.1%
6/26 • Number of events 6
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
33.3%
7/21 • Number of events 7
|
11.5%
3/26 • Number of events 3
|
|
General disorders
Pyrexia
|
14.3%
3/21 • Number of events 3
|
0.00%
0/26
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Number of events 4
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract infection
|
4.8%
1/21 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place