Trial Outcomes & Findings for Study for Short Term Weight Loss in Candidates for Bariatric Surgery (NCT NCT00985491)
NCT ID: NCT00985491
Last Updated: 2016-09-15
Results Overview
Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as \[(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)\] \* 100).
COMPLETED
PHASE2
46 participants
12 months
2016-09-15
Participant Flow
Participant milestones
| Measure |
EndoBarrier Liner Device
All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
Received Device
|
43
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
EndoBarrier Liner Device
All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
device migration
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
implant failure
|
3
|
Baseline Characteristics
Study for Short Term Weight Loss in Candidates for Bariatric Surgery
Baseline characteristics by cohort
| Measure |
EndoBarrier Liner Device
n=43 Participants
46 subjects were enrolled. 3 subjects were implant failures. 43 Subjects received the device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
43 participants
n=5 Participants
|
|
HbA1c
|
7.7 %
STANDARD_DEVIATION 2.03 • n=5 Participants
|
|
Baseline Weight
|
110.3 kg
STANDARD_DEVIATION 18.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPrimary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as \[(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)\] \* 100).
Outcome measures
| Measure |
EndoBarrier Liner Device
n=27 Participants
All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Assessment of % Excess Weight Loss
|
45.4 %EWL
Standard Error 20.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 7 subjects were enrolled that had Type 2 Diabetes; endpoint evaluated subjects who achieved HbA1c reduction of 0.5%
Subjects who achieved HbA1c reduction of 0.5%
Outcome measures
| Measure |
EndoBarrier Liner Device
n=7 Participants
All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Improvement in Type 2 Diabetic Status
|
57.1 % of subjects with T2DM
|
Adverse Events
EndoBarrier Liner Device
Serious adverse events
| Measure |
EndoBarrier Liner Device
n=46 participants at risk
All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
41.3%
19/46 • Number of events 19
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
3/46 • Number of events 3
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/46 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
4.3%
2/46 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Endoscopy
|
2.2%
1/46 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumor
|
2.2%
1/46 • Number of events 1
|
Other adverse events
| Measure |
EndoBarrier Liner Device
n=46 participants at risk
All patients will be implanted with the Endobarrier Liner device.
Endobarrier Liner: Medical device placed endoscopically in the duodenum
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
78.3%
36/46 • Number of events 78
|
|
Gastrointestinal disorders
Nausea
|
32.6%
15/46 • Number of events 18
|
|
Gastrointestinal disorders
Vomiting
|
32.6%
15/46 • Number of events 21
|
|
Gastrointestinal disorders
Procedural nausea
|
17.4%
8/46 • Number of events 8
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
17.4%
8/46 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
3/46 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
6.5%
3/46 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
4/46 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place