ObesityNCT02518685
ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
A study testing TransPyloric Shuttle and Lifestyle Counseling in people with Obesity, run by BaroNova, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- TransPyloric Shuttle and Lifestyle Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 36Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Baylor University Medical Center
Dallas, Texas, 75246
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
MidSouth Bariatrics
Memphis, Tennessee, 38120
University of Miami
Miami, Florida, 33166
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of California San Diego
San Diego, California, 92103
HonorHealth Bariatric Center
Scottsdale, Arizona, 85258
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook Medicine
Stony Brook, New York, 11794
About this study
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
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.
- Conditions
- Obesity
- Being tested
- TransPyloric Shuttle, Sham procedure, Lifestyle Counseling
- Keywords
- Obesity, Weight loss, Device, Non-surgical, Endoscopic, TransPyloric Shuttle, TPS
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransPyloric ShuttleDevice
Also called TPS
Sham procedureDevice
Lifestyle CounselingBehavioural
The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
| Study group | Role | What they receive |
|---|---|---|
| TransPyloric Shuttle (TPS) | Experimental | TransPyloric Shuttle plus Lifestyle Counseling Receives: Device: TransPyloric Shuttle; Behavioral: Lifestyle Counseling |
| Control | Sham comparator | Sham procedure plus Lifestyle Counseling Receives: Device: Sham procedure; Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
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%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- BaroNova, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard I Rothstein, MD, Principal investigator, Dartmouth Geisel School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518685
- Sponsor's protocol ID
- DTC006
- Status last verified
- Apr 2019
- First submitted
- 6 Aug 2015
- Last updated
- 17 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02518685
- Acronym / sponsor ID
- DTC006
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Device, Non-surgical, Endoscopic, TransPyloric Shuttle, TPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- BaroNova, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Posted 17 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TransPyloric Shuttle (TPS) | Experimental | Device: TransPyloric Shuttle, Behavioral: Lifestyle CounselingTransPyloric Shuttle plus Lifestyle Counseling |
| Control | Sham comparator | Device: Sham procedure, Behavioral: Lifestyle CounselingSham procedure plus Lifestyle Counseling |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransPyloric ShuttleAlso: TPS | Device | TransPyloric Shuttle (TPS) |
| Sham procedure | Device | Control |
| Lifestyle CounselingThe goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies. | Behavioural | Control, TransPyloric Shuttle (TPS) |
Primary outcome
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group
Time frame: 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
Time frame: 12 months
The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard I Rothstein, MD principal investigator
Dartmouth Geisel School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransPyloric Shuttle and Lifestyle Counseling in people with Obesity, run by BaroNova, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.