Obesity
Conditions
Keywords
Obesity, Weight loss, Device, Non-surgical, Endoscopic, TransPyloric Shuttle, TPS
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.
Interventions
DEVICETransPyloric Shuttle
DEVICESham procedure
BEHAVIORALLifestyle 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.
Sponsors
BaroNova, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TransPyloric Shuttle (TPS) TransPyloric Shuttle plus lifestyle counseling | 181 |
| Control Sham procedure plus lifestyle counseling. | 89 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 29 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | relocation, study fatigue | 7 | 2 |
| Overall Study | Withdrawal by Subject | 10 | 3 |
Baseline characteristics
| Characteristic | TransPyloric Shuttle (TPS) | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 181 Participants | 89 Participants | 270 Participants |
| Age, Continuous | 43.0 years STANDARD_DEVIATION 8.9 | 43.9 years STANDARD_DEVIATION 8.5 | 43.3 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 12 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 153 Participants | 77 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 13 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 131 Participants | 65 Participants | 196 Participants |
| Region of Enrollment United States | 181 participants | 89 participants | 270 participants |
| Sex: Female, Male Female | 169 Participants | 83 Participants | 252 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 0 / 89 |
| other Total, other adverse events | 203 / 203 | 87 / 89 |
| serious Total, serious adverse events | 10 / 213 | 1 / 89 |
Outcome results
Primary
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline
Time frame: 12 Months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TransPyloric Shuttle (TPS) | Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group | 9.5 % Total Body Weight Loss | Standard Error 0.65 |
| Control | Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group | 2.8 % Total Body Weight Loss | Standard Error 0.87 |
p-value: <0.000195% CI: [4.54, 8.81]multiple imputations
Primary
Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL
The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Time frame: 12 months
Population: Per Protocol Population; received TPS Device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TransPyloric Shuttle (TPS) | Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL | 112 Participants |
p-value: <0.000195% CI: [59.3, 74.3]Wilson's Midpoint Estimate