Trial Outcomes & Findings for ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss (NCT NCT02518685)
NCT ID: NCT02518685
Last Updated: 2019-07-17
Results Overview
The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
12 Months
Results posted on
2019-07-17
Participant Flow
Participant milestones
| Measure |
TransPyloric Shuttle (TPS)
TransPyloric Shuttle plus lifestyle counseling
|
Control
Sham procedure plus lifestyle counseling.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
89
|
|
Overall Study
Safety Cohort
|
203
|
89
|
|
Overall Study
Randomized Cohort
|
181
|
89
|
|
Overall Study
Enrolled
|
213
|
89
|
|
Overall Study
Per Protocol Analysis
|
168
|
89
|
|
Overall Study
COMPLETED
|
164
|
79
|
|
Overall Study
NOT COMPLETED
|
49
|
10
|
Reasons for withdrawal
| Measure |
TransPyloric Shuttle (TPS)
TransPyloric Shuttle plus lifestyle counseling
|
Control
Sham procedure plus lifestyle counseling.
|
|---|---|---|
|
Overall Study
Adverse Event
|
29
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
|
Overall Study
relocation, study fatigue
|
7
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
Baseline Characteristics
ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
Baseline characteristics by cohort
| Measure |
TransPyloric Shuttle (TPS)
n=181 Participants
TransPyloric Shuttle plus lifestyle counseling
|
Control
n=89 Participants
Sham procedure plus lifestyle counseling.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
181 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
169 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
230 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
|
1 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
181 participants
n=5 Participants
|
89 participants
n=7 Participants
|
270 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsThe mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Outcome measures
| Measure |
TransPyloric Shuttle (TPS)
n=168 Participants
TransPyloric Shuttle plus lifestyle counseling
TransPyloric Shuttle
lifestyle counseling
|
Control
n=89 Participants
Sham procedure plus lifestyle counseling.
lifestyle counseling
Sham procedure
|
|---|---|---|
|
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
|
9.5 % Total Body Weight Loss
Standard Error 0.65
|
2.8 % Total Body Weight Loss
Standard Error 0.87
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Per Protocol Population; received TPS Device
The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Outcome measures
| Measure |
TransPyloric Shuttle (TPS)
n=168 Participants
TransPyloric Shuttle plus lifestyle counseling
TransPyloric Shuttle
lifestyle counseling
|
Control
Sham procedure plus lifestyle counseling.
lifestyle counseling
Sham procedure
|
|---|---|---|
|
Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
|
112 Participants
|
—
|
Adverse Events
TransPyloric Shuttle (TPS)
Serious events: 10 serious events
Other events: 203 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TransPyloric Shuttle (TPS)
n=203 participants at risk；n=213 participants at risk
TransPyloric Shuttle plus lifestyle counseling
|
Control
n=89 participants at risk
Sham procedure plus lifestyle counseling.
|
|---|---|---|
|
Gastrointestinal disorders
esophageal rupture
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
upper abdominal pain
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
gastric ulcer
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
vomiting
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
General disorders
device intolerance
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
gastric obstruction
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
1.1%
1/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Hepatobiliary disorders
cholelithiasis
|
1.4%
3/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
divericularitis
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meningioma
|
0.47%
1/213 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
Other adverse events
| Measure |
TransPyloric Shuttle (TPS)
n=203 participants at risk；n=213 participants at risk
TransPyloric Shuttle plus lifestyle counseling
|
Control
n=89 participants at risk
Sham procedure plus lifestyle counseling.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
64.5%
131/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
39.3%
35/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
abdominal pain upper
|
63.1%
128/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
41.6%
37/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
vomiting
|
62.1%
126/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
15.7%
14/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
dyspepsia
|
55.7%
113/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
34.8%
31/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
diarrhea
|
51.7%
105/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
32.6%
29/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
abdominal distension
|
37.9%
77/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
19.1%
17/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
gastroesophageal reflux
|
35.5%
72/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
25.8%
23/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
eructation
|
33.0%
67/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
10.1%
9/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
constipation
|
23.2%
47/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
9.0%
8/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
gastritis, erosive
|
14.3%
29/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
3.4%
3/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
gastric mucosa erythema
|
12.3%
25/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
3.4%
3/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
gastric ulcer
|
10.3%
21/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
0.00%
0/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
abdominal pain
|
8.4%
17/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
1.1%
1/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Gastrointestinal disorders
abdominal pain lower
|
7.4%
15/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
3.4%
3/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
36.9%
75/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
49.4%
44/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Infections and infestations
nasopharyngitis
|
5.9%
12/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
12.4%
11/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Injury, poisoning and procedural complications
esophageal mucosal injury
|
8.9%
18/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
9.0%
8/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
General disorders
pyrexia
|
5.9%
12/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
3.4%
3/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
General disorders
pain
|
5.4%
11/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
3.4%
3/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
|
Nervous system disorders
headache
|
7.9%
16/203 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
7.9%
7/89 • 12 months
The TPS, SAE population includes all subjects successful deliveries plus 10 subjects with attempted deliveries. The TPS, AE population includes successful deliveries where the TPS remained for up to one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place