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Trial record 1 of 1 for:    NCT02518685
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ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518685
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
BaroNova, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity
Interventions Device: TransPyloric Shuttle
Device: Sham procedure
Behavioral: Lifestyle Counseling
Enrollment 302
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TransPyloric Shuttle (TPS) Control
Hide Arm/Group Description TransPyloric Shuttle plus lifestyle counseling Sham procedure plus lifestyle counseling.
Period Title: Overall Study
Started [1] 213 89
Safety Cohort [2] 203 [3] 89
Randomized Cohort 181 89
Enrolled 213 [4] 89
Per Protocol Analysis 168 [5] 89
Completed [6] 164 [7] 79
Not Completed 49 10
Reason Not Completed
Adverse Event             29             1
Withdrawal by Subject             10             3
relocation, study fatigue             7             2
Pregnancy             1             0
Physician Decision             1             0
Lost to Follow-up             1             4
[1]
Subjects randomized
[2]
Ten subjects did not receive TPS
[3]
Randomized to and successfully received TPS (171) + Open-Label TPS-treated Subjects (32)
[4]
Includes 171 Successful device deployments, 10 unsuccessful delivery attempts and 32 Open-Label
[5]
Three TPS-treated subjects were inadvertently unblinded, excluding them from efficacy analyses.
[6]
Completed 12-Month Visit
[7]
Randomized Completers (139) plus Open-Label Completers (25)
Arm/Group Title TransPyloric Shuttle (TPS) Control Total
Hide Arm/Group Description TransPyloric Shuttle plus lifestyle counseling Sham procedure plus lifestyle counseling. Total of all reporting groups
Overall Number of Baseline Participants 181 89 270
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 89 participants 270 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
181
 100.0%
89
 100.0%
270
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants 89 participants 270 participants
43.0  (8.9) 43.9  (8.5) 43.3  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 89 participants 270 participants
Female
169
  93.4%
83
  93.3%
252
  93.3%
Male
12
   6.6%
6
   6.7%
18
   6.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 89 participants 270 participants
Hispanic or Latino
28
  15.5%
12
  13.5%
40
  14.8%
Not Hispanic or Latino
153
  84.5%
77
  86.5%
230
  85.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 89 participants 270 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
1
   0.4%
Asian
1
   0.6%
0
   0.0%
1
   0.4%
Native Hawaiian or Other Pacific Islander
1
   0.6%
1
   1.1%
2
   0.7%
Black or African American
32
  17.7%
13
  14.6%
45
  16.7%
White
131
  72.4%
65
  73.0%
196
  72.6%
More than one race
13
   7.2%
6
   6.7%
19
   7.0%
Unknown or Not Reported
2
   1.1%
4
   4.5%
6
   2.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 181 participants 89 participants 270 participants
181 89 270
1.Primary Outcome
Title Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
Hide Description The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TransPyloric Shuttle (TPS) Control
Hide Arm/Group Description:

TransPyloric Shuttle plus lifestyle counseling

TransPyloric Shuttle

lifestyle counseling

Sham procedure plus lifestyle counseling.

lifestyle counseling

Sham procedure

Overall Number of Participants Analyzed 168 89
Least Squares Mean (Standard Error)
Unit of Measure: % Total Body Weight Loss
9.5  (0.65) 2.8  (0.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TransPyloric Shuttle (TPS), Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method multiple imputations
Comments [Not Specified]
Method of Estimation Estimation Parameter Least-Square Mean Difference
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
4.54 to 8.81
Estimation Comments [Not Specified]
2.Primary Outcome
Title Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
Hide Description The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population; received TPS Device
Arm/Group Title TransPyloric Shuttle (TPS)
Hide Arm/Group Description:
TransPyloric Shuttle plus lifestyle counseling
Overall Number of Participants Analyzed 168
Measure Type: Count of Participants
Unit of Measure: Participants
112
  66.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TransPyloric Shuttle (TPS)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilson's Midpoint Estimate
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion of Subjects
Estimated Value 66.8
Confidence Interval (2-Sided) 95%
59.3 to 74.3
Estimation Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description

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

 
Arm/Group Title TransPyloric Shuttle (TPS) Control
Hide Arm/Group Description TransPyloric Shuttle plus lifestyle counseling Sham procedure plus lifestyle counseling.
All-Cause Mortality
TransPyloric Shuttle (TPS) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/213 (0.00%)   0/89 (0.00%) 
Hide Serious Adverse Events
TransPyloric Shuttle (TPS) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   10/213 (4.69%)   1/89 (1.12%) 
Gastrointestinal disorders     
esophageal rupture  1  1/213 (0.47%)  0/89 (0.00%) 
upper abdominal pain  1  1/213 (0.47%)  0/89 (0.00%) 
gastric ulcer  1  1/213 (0.47%)  0/89 (0.00%) 
vomiting  1  1/213 (0.47%)  0/89 (0.00%) 
gastric obstruction  1  1/213 (0.47%)  0/89 (0.00%) 
divericularitis  1 [1]  1/213 (0.47%)  0/89 (0.00%) 
General disorders     
device intolerance  1  1/213 (0.47%)  0/89 (0.00%) 
Hepatobiliary disorders     
cholelithiasis  1 [1]  3/213 (1.41%)  0/89 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
meningioma  1 [1]  1/213 (0.47%)  0/89 (0.00%) 
Nervous system disorders     
cerebrovascular accident  1 [1]  0/213 (0.00%)  1/89 (1.12%) 
Respiratory, thoracic and mediastinal disorders     
pneumothorax  1 [2]  1/213 (0.47%)  0/89 (0.00%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
[1]
not device or procedure related
[2]
due to esophageal rupture in same patient
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TransPyloric Shuttle (TPS) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   203/203 (100.00%)   87/89 (97.75%) 
Gastrointestinal disorders     
nausea  1  131/203 (64.53%)  35/89 (39.33%) 
abdominal pain upper  1  128/203 (63.05%)  37/89 (41.57%) 
vomiting  1  126/203 (62.07%)  14/89 (15.73%) 
dyspepsia  1  113/203 (55.67%)  31/89 (34.83%) 
diarrhea  1  105/203 (51.72%)  29/89 (32.58%) 
abdominal distension  1  77/203 (37.93%)  17/89 (19.10%) 
gastroesophageal reflux  1  72/203 (35.47%)  23/89 (25.84%) 
eructation  1  67/203 (33.00%)  9/89 (10.11%) 
constipation  1  47/203 (23.15%)  8/89 (8.99%) 
gastritis, erosive  1  29/203 (14.29%)  3/89 (3.37%) 
gastric mucosa erythema  1  25/203 (12.32%)  3/89 (3.37%) 
gastric ulcer  1  21/203 (10.34%)  0/89 (0.00%) 
abdominal pain  1  17/203 (8.37%)  1/89 (1.12%) 
abdominal pain lower  1  15/203 (7.39%)  3/89 (3.37%) 
General disorders     
pyrexia  1  12/203 (5.91%)  3/89 (3.37%) 
pain  1  11/203 (5.42%)  3/89 (3.37%) 
Infections and infestations     
nasopharyngitis  1  12/203 (5.91%)  11/89 (12.36%) 
Injury, poisoning and procedural complications     
esophageal mucosal injury  1 [1]  18/203 (8.87%)  8/89 (8.99%) 
Nervous system disorders     
headache  1  16/203 (7.88%)  7/89 (7.87%) 
Respiratory, thoracic and mediastinal disorders     
oropharyngeal pain  1  75/203 (36.95%)  44/89 (49.44%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
[1]
endoscopic observations during procedure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lian Cunningham, MD, PhD
Organization: BAROnova, Inc
Phone: 650.638.9796 ext 22
EMail: lcunningham@baronova.com
Layout table for additonal information
Responsible Party: BaroNova, Inc.
ClinicalTrials.gov Identifier: NCT02518685    
Other Study ID Numbers: DTC006
First Submitted: August 6, 2015
First Posted: August 10, 2015
Results First Submitted: April 20, 2019
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019