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

NCT01386905 | Completed DMC

• 1 other identifier: TPSS-I-0409-B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility of the TransPyloric Shuttle™ System (TPS™)

  Preliminary evidence of the effectiveness of the TPS™ as determined by percent weight loss, excess BMI loss, and excess weight loss.

  Up to 6 months post-placement

Secondary Outcomes (2)

• Effect of the TransPyloric Shuttle™ (TPS™) on Patient Quality of Life

  Up to 6 months post-placement

• Safety of the TransPyloric Shuttle™ (TPS™)

  Up to 6 months post-placement

Interventions

BAROnova™ TransPyloric Shuttle™ (TPS™) DEVICE

Subjects will undergo an endoscopic procedure to deliver the TPS™ into the stomach. The TPS™ moves freely without any physical attachment or invasive anchoring to tissue to reduce gastric outflow.

Also known as: ENDObesity I Study™, BAROnova™, TransPyloric Shuttle™, TPS™

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects between the ages of 18 to 55.
• BMI between 30 to 50 kg/m2. Subjects with BMI ≥ 35 to 50 kg/m2 inclusive, and subjects with a BMI of 30.0 to 34.9 kg/m2 are required to have one or more of the following obesity-related co-morbidities.
• Diabetes: controlled diabetic, and if on insulin, has been on the medication of less than two years.
• Sleep apnea: Apnea/hypopnea index or AHI \> 30 events/hour.
• Hypertension: arterial blood pressure \> 140 mmHg systolic or \> 90 mmHg diastolic
• Osteoarthritis of the hip or knee.
• Gastro Esophageal Reflux Disease (GERD): Persistent reflux that occurs more than twice a week.
• History of stable weight (defined as a \< 10% change in excess weight) for one year prior to screening visit.
• 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.
• History of obesity for at least five years.
• 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.
• Lives within the drawing area of the hospital.
• Willing and able to return for all study visits.

You may not qualify if:

• Currently untreated thyroid and adrenal gland disease.
• Females who are either pregnant or breastfeeding.
• Insulin-dependent diabetic, where the subject has been on medication for more than two years.
• Uncontrolled hypertension defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg.
• Ischemic heart disease.
• Previous stroke.
• Previous myocardial infarct within 180 days of the study.
• 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 the LAP-BAND® or equivalent.
• Prior treatment with an intragastric balloon for the purpose of weight loss, where the balloon was removed less than 12 months prior to screening.
• A structural abnormality in the esophagus, pharynx (such as a stricture), or pylorus (such as an incompetent pylorus).
• Portal hypertension, cirrhosis, and/or varices.
• Inflammatory disease, such as Crohn's disease, where the disease is affecting the stomach.
• Acute abdominal infections.
• Active gastric or duodenal ulcer.
• A history of severe dyspepsia or gastric or duodenal ulcer disease.

Sponsors & Collaborators

• BaroNova, Inc.: lead

Study Sites (1)

Gastric Balloon Australia (GBA)

Bondi Junction, New South Wales, 2022, Australia

Location

Related Publications (3)

• Schols AM, Slangen J, Volovics L, Wouters EF. Weight loss is a reversible factor in the prognosis of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1791-7. doi: 10.1164/ajrccm.157.6.9705017.

  PMID: 9620907 BACKGROUND

• Sampalis JS, Liberman M, Auger S, Christou NV. The impact of weight reduction surgery on health-care costs in morbidly obese patients. Obes Surg. 2004 Aug;14(7):939-47. doi: 10.1381/0960892041719662.

  PMID: 15329183 BACKGROUND

• http://www.oecd.org/document/16/0,2340,en_2649_34631_2085200_1_1_1_1,00.html

  RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• George Marinos, MD

  Gastric Balloon Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

AU (1)