ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss

• Sponsor: BaroNova, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02518685
• Collaborator: (none)
• Enrollment: 302
• Locations: 9
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 33.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this clinical research trial is to study safety and effectiveness of the TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered medically obese.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: TransPyloric Shuttle; Device: Sham procedure; Behavioral: Lifestyle Counseling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 302 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Endoscopic Treatment for Weight Reduction in Patients With Obesity Using the TransPyloric Shuttle® System: A Multicenter, Prospective, Randomized, Double-Blind, Sham-Controlled, Parallel-Design Study
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TransPyloric Shuttle (TPS) TransPyloric Shuttle plus Lifestyle Counseling	Device: TransPyloric Shuttle; Other Names: TPS ; Behavioral: Lifestyle Counseling; The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
Sham Comparator: Control Sham procedure plus Lifestyle Counseling	Device: Sham procedure; Behavioral: Lifestyle Counseling; The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.

Outcome Measures

Primary Outcome Measures

1. Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group [12 Months]

   The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline

2. Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL [12 months]

   The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female subjects between the ages of 22 to 60

• A BMI between 30.0 to 40.0 kg/m2, inclusive. Subjects with a BMI of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities

• History of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program

• < 5% change in body weight for at least 3 months

• Negative pregnancy test, agree to be on birth control for the duration of participation

• Informed consent

• Willing and able to comply with study procedures

Exclusion Criteria:

• Pregnancy or nursing

• Hormonal or genetic cause for obesity

• Prior history of any GI surgery or endoscopic intervention

• Chronic use of medications likely to contribute to weight gain or prevent weight loss

• Gastric or duodenal ulcers

• Positive for H. pylori

• History of severe dyspepsia

• GI tract motility disorders

• History of inflammatory disease of GI tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices

• Diabetes treated with insulin

• HbA1c >7.5%

• Uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension

• History of certain cardiac events

• Localized or systemic infection

• Anemia

• History of asthma likely to require systemic steroid therapy

• Autoimmune connective tissue disorders or immunocompromised

• History of malignancy except non-melanoma skin cancer

• Continuous use of ulcerogenic medication

• On anticoagulation or antiplatelet therapy

• Use of weight-loss medication

• In other weight-loss program

• Unable to take proton pump inhibitor

• Abnormal laboratory values or EKG

• Inability to walk at least 0.8 kilometers per day

• Planned surgical procedure that can impact the conduct of the study

• Known allergy to any component materials in the TPSS

• Smoker or user of nicotine product

• Substance abuse

• Severe, uncontrolled psychiatric illness

• Recent inpatient psychiatric treatment

• Moderate depression

• Bulimia nervosa or binge eating disorder

• Participation in another clinical study

• Employee or family member of Sponsor or study staff

• Have any endoscopic exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Bariatric Center	Scottsdale	Arizona	United States	85258
2	University of California San Diego	San Diego	California	United States	92103
3	University of Miami	Miami	Florida	United States	33166
4	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
5	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
6	Stony Brook Medicine	Stony Brook	New York	United States	11794
7	MidSouth Bariatrics	Memphis	Tennessee	United States	38120
8	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
9	Baylor University Medical Center	Dallas	Texas	United States	75246

Sponsors and Collaborators

• BaroNova, Inc.

Investigators

• Principal Investigator: Richard I Rothstein, MD, Dartmouth Geisel School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 15, 2016

More Information

Publications

None provided.

• Responsible Party: BaroNova, Inc.
• ClinicalTrials.gov Identifier: NCT02518685
• Other Study ID Numbers: DTC006
• First Posted: Aug 10, 2015
• Last Update Posted: Jul 17, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by BaroNova, Inc.: Obesity; Weight loss; Device; Non-surgical; Endoscopic; TransPyloric Shuttle; TPS
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	TransPyloric Shuttle (TPS)	Control
Arm/Group Description	TransPyloric Shuttle plus lifestyle counseling	Sham procedure plus lifestyle counseling.
Period Title: Overall Study
STARTED	213	89
Safety Cohort	203	89
Randomized Cohort	181	89
Enrolled	213	89
Per Protocol Analysis	168	89
COMPLETED	164	79
NOT COMPLETED	49	10

Baseline Characteristics

Arm/Group Title	TransPyloric Shuttle (TPS)	Control	Total
Arm/Group Description	TransPyloric Shuttle plus lifestyle counseling	Sham procedure plus lifestyle counseling.	Total of all reporting groups
Overall Participants	181	89	270
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	181 100%	89 100%	270 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.0 (8.9)	43.9 (8.5)	43.3 (8.6)
Sex: Female, Male (Count of Participants)
Female	169 93.4%	83 93.3%	252 93.3%
Male	12 6.6%	6 6.7%	18 6.7%
Ethnicity (NIH/OMB) (Count of 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%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.6%	0 0%	1 0.4%
Asian	1 0.6%	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%	196 72.6%
More than one race	13 7.2%	6 6.7%	19 7%
Unknown or Not Reported	2 1.1%	4 4.5%	6 2.2%
Region of Enrollment (participants) [Number]
United States	181 100%	89 100%	270 100%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
Description	The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TransPyloric Shuttle (TPS)	Control
Arm/Group Description	TransPyloric Shuttle plus lifestyle counseling TransPyloric Shuttle lifestyle counseling	Sham procedure plus lifestyle counseling. lifestyle counseling Sham procedure
Measure Participants	168	89
Least Squares Mean (Standard Error) [% Total Body Weight Loss]	9.5 (0.65)	2.8 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TransPyloric Shuttle (TPS), Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	multiple imputations
	Comments
Method of Estimation	Estimation Parameter	Least-Square Mean Difference
	Estimated Value	6.7
	Confidence Interval	(2-Sided) 95%; 4.54 to 8.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
Description	The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Per Protocol Population; received TPS Device

Arm/Group Title	TransPyloric Shuttle (TPS)
Arm/Group Description	TransPyloric Shuttle plus lifestyle counseling
Measure Participants	168
Count of Participants [Participants]	112 61.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TransPyloric Shuttle (TPS)
	Comments
	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
	Method	Wilson's Midpoint Estimate
	Comments
Method of Estimation	Estimation Parameter	Proportion of Subjects
	Estimated Value	66.8
	Confidence Interval	(2-Sided) 95%; 59.3 to 74.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
Arm/Group Description	TransPyloric Shuttle plus lifestyle counseling		Sham procedure plus lifestyle counseling.
All Cause Mortality
	TransPyloric Shuttle (TPS)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/213 (0%)		0/89 (0%)
Serious Adverse Events
	TransPyloric Shuttle (TPS)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/213 (4.7%)		1/89 (1.1%)
Gastrointestinal disorders
esophageal rupture	1/213 (0.5%)		0/89 (0%)
upper abdominal pain	1/213 (0.5%)		0/89 (0%)
gastric ulcer	1/213 (0.5%)		0/89 (0%)
vomiting	1/213 (0.5%)		0/89 (0%)
gastric obstruction	1/213 (0.5%)		0/89 (0%)
divericularitis	1/213 (0.5%)		0/89 (0%)
General disorders
device intolerance	1/213 (0.5%)		0/89 (0%)
Hepatobiliary disorders
cholelithiasis	3/213 (1.4%)		0/89 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
meningioma	1/213 (0.5%)		0/89 (0%)
Nervous system disorders
cerebrovascular accident	0/213 (0%)		1/89 (1.1%)
Respiratory, thoracic and mediastinal disorders
pneumothorax	1/213 (0.5%)		0/89 (0%)
Other (Not Including Serious) Adverse Events
	TransPyloric Shuttle (TPS)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	203/203 (100%)		87/89 (97.8%)
Gastrointestinal disorders
nausea	131/203 (64.5%)		35/89 (39.3%)
abdominal pain upper	128/203 (63.1%)		37/89 (41.6%)
vomiting	126/203 (62.1%)		14/89 (15.7%)
dyspepsia	113/203 (55.7%)		31/89 (34.8%)
diarrhea	105/203 (51.7%)		29/89 (32.6%)
abdominal distension	77/203 (37.9%)		17/89 (19.1%)
gastroesophageal reflux	72/203 (35.5%)		23/89 (25.8%)
eructation	67/203 (33%)		9/89 (10.1%)
constipation	47/203 (23.2%)		8/89 (9%)
gastritis, erosive	29/203 (14.3%)		3/89 (3.4%)
gastric mucosa erythema	25/203 (12.3%)		3/89 (3.4%)
gastric ulcer	21/203 (10.3%)		0/89 (0%)
abdominal pain	17/203 (8.4%)		1/89 (1.1%)
abdominal pain lower	15/203 (7.4%)		3/89 (3.4%)
General disorders
pyrexia	12/203 (5.9%)		3/89 (3.4%)
pain	11/203 (5.4%)		3/89 (3.4%)
Infections and infestations
nasopharyngitis	12/203 (5.9%)		11/89 (12.4%)
Injury, poisoning and procedural complications
esophageal mucosal injury	18/203 (8.9%)		8/89 (9%)
Nervous system disorders
headache	16/203 (7.9%)		7/89 (7.9%)
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain	75/203 (36.9%)		44/89 (49.4%)

Limitations/Caveats

[Not Specified]

More Information

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.