Text Size

A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BaroNova, Inc.
ClinicalTrials.gov Identifier:
NCT01386905
First received: June 30, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to assess the safety and effectiveness of the TransPyloric Shuttle™ (TPS™) when used to treat obesity.

The Null Hypothesis is that the mean percent Excess Weight Loss (EWL) at 12 weeks will be equal to the mean percent EWL at 12 weeks for historical controls; whereas, the Alternative Hypothesis is that the two means are not equal.


Condition Intervention
Obesity
 Device: BAROnova™ TransPyloric Shuttle™ (TPS™)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (ENDObesity™ I Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BaroNova, Inc.:

Primary Outcome Measures:
  • Safety of the TransPyloric Shuttle™ System (TPSS) [ Time Frame: Up to 6 months post-placement ] [ Designated as safety issue: Yes ]
    Safety of the TPSS in obese subjects as evidenced by the rate of adverse device effects.


Secondary Outcome Measures:
  • Effectiveness of the TransPyloric Shuttle™ (TPS™) [ Time Frame: Up to 6 months post-placement ] [ Designated as safety issue: No ]
    Preliminary evidence of the effectiveness of the TPS™ as determined by the percent of excess weight loss (%EWL) and reduction in body circumference measurements.


Estimated Enrollment: 50
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: BAROnova™ TransPyloric Shuttle™ (TPS™)
    Each subject will be treated with the TPS™. Up to 50 subjects meeting the inclusion/exclusion criteria will be enrolled. On study Day 0, subjects will undergo an endoscopic procedure to deliver the TPS™ into the stomach. The TPS™ can reside in the stomach for approximately 180 days.
    Other Names:
    • ENDObesity I Study™
    • BAROnova™
    • TransPyloric Shuttle™
    • TPS™
Detailed Description:

The number of people who are overweight or obese has been steadily rising. In Australia, in 1980, 8.3% of the population was considered obese. By 2010, the Australian obesity rate had risen to 24.8%.

Weight loss significantly decreases early mortality as well as the development of new health-related conditions in obese subjects, and can improve many of the co-morbidities associated with obesity.

Therapies include drugs, surgery and treatment with medical devices, such as gastric banding and intragastric balloons. The TransPyloric Shuttle™ (TPS™) is a medical device that is endoscopically delivered and removed from the stomach. The TPS™ is designed to self-position across the pylorus and create an intermittent obstruction to outflow that may result in delayed gastric emptying. Slowing gastric emptying may enable an overall reduction in caloric intake by helping the subject feel full sooner (early satiation) and/or feel full longer (prolonged satiety/reduced hunger).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects between the ages of 18 to 55
  2. BMI between 30 to 50 kg/m2
  3. History of stable weight
  4. Female subjects of childbearing potential must have a negative urine pregnancy test and must agree to practice a medically acceptable form of birth control for the duration of their participation in the trial
  5. History of obesity for at least five years
  6. Subjects must be able to read and understand their native language at a level allowing the subject to understand and sign the informed consent prior to the performance of any study-specific procedure
  7. Lives within the drawing area of the hospital
  8. Willing and able to return for all study visits

Exclusion Criteria:

  1. Females who are either pregnant or breastfeeding
  2. Insulin-dependent diabetic, where the subject has been on medication for more than two years
  3. Uncontrolled hypertension
  4. Ischemic heart disease
  5. Previous stroke
  6. Previous myocardial infarct within 180 days of the study
  7. Prior history of bariatric surgery, such as gastric bypass, or any surgery that has altered the esophagus, stomach, or pylorus, and restrictive procedures such as laparoscopic adjustable gastric banding
  8. Prior treatment with an intragastric balloon for the purpose of weight loss, where the balloon was removed less than 12 month prior to screening
  9. Works for BAROnova or the study doctor or is directly-related to anyone that works for BAROnova or the study doctor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386905

Locations
Australia, New South Wales
Gastric Balloon Australia (GBA)
Bondi Junction, New South Wales, Australia, 2022
Sponsors and Collaborators
BaroNova, Inc.
Investigators
Principal Investigator: George Marinos, MD Gastric Balloon Australia
  More Information

Publications:

Responsible Party: BaroNova, Inc.
ClinicalTrials.gov Identifier: NCT01386905     History of Changes
Other Study ID Numbers: TPSS-I-0409-B
Study First Received: June 30, 2011
Last Updated: October 9, 2012
Health Authority: Australia: Ethics Committee

Keywords provided by BaroNova, Inc.:
Obesity

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013