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ObesityNCT01386905

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

A study testing BAROnova™ TransPyloric Shuttle™ (TPS™) in people with Obesity, run by BaroNova, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity
What is being tested?
BAROnova™ TransPyloric Shuttle™ (TPS™)
Type of treatment
Medical device
How many people
20 participants
Where
1 siteAustralia
Study dates
Jun 2011to May 2012
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • After treatment for H. pylori, patient still tests positive for H. pylori.
  • Evidence of erosive esophagitis.
  • Subject with a hiatal hernia ≥ 2 cm.
  • Subjects with motility disorders of the GI tract such as esophageal motility disorders, gastroparesis diabeticorum, or intractable constipation.
  • Use of any prescription or over-the-counter weight loss medication, including herbal supplements, within three months of TPS device placement.
  • Subjects requiring continuous therapy with known ulcerogenic medication (e.g. aspirin, including 80 mg ASA or NSAIDs).
  • Subjects on anticoagulant therapy, such as those taking Coumadin, Warfarin, Heparin or Plavix.
  • Subjects unable to take a daily 40+ mg dose of Nexium or generic equivalent or 800+ mcg of Misoprostol or general equivalent.
  • Clinically significant abnormal laboratory values or EKG that make the subject a poor study candidate in the opinion of the investigator.
  • Subjects with autoimmune connective tissue disorders.
  • A history of cardiac arrhythmia or severe cardiac disease (NYHA Class III or IV).
  • Cannot walk at least 0.8 kilometers per day (10 minutes of continuous walking).
  • Subjects who have started on a prescribed concomitant medication regimen within the last three weeks, and/or whose concomitant medication regimen is expected to change during the course of the study, and where the Investigator determines the medication may affect the study outcome.
  • Treatment for drug abuse, alcohol abuse, or inpatient psychiatric treatment within the past year.
  • Any medical condition (including psychiatric disease) that would interfere with the interpretation of the study results, the conduct of the study, or would not be in the best interest of the subject.
  • A score of ≥ 10 on the Patient Health Questionnaire 9 (PHQ-9), indicating moderate depression.
  • Subjects who are in a dysfunctional relationship (e.g. an alcoholic spouse, the victim of sexual, verbal, or physical abuse, etc.).
  • Participation in a trial of an investigational drug or device within 30 days prior to Screening Visit or plans to enroll in an investigational drug or device trial at any time during this study.
  • Works for BAROnova or the study doctor or is directly-related to anyone that works for BAROnova or the study doctor.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Gastric Balloon Australia (GBA)

    Bondi Junction, New South Wales, 2022

Other trials in Australia

About this study

Official title: A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects (ENDObesity™ I Study)

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

Read the 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).

Conditions
Obesity
Being tested
BAROnova™ TransPyloric Shuttle™ (TPS™)
Keywords
Obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAROnova™ TransPyloric Shuttle™ (TPS™)Device

    Also called ENDObesity I Study™, BAROnova™, TransPyloric Shuttle™, TPS™

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months post-placement

Secondary outcomes (2)

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

    Preliminary evidence of the effect of TPS™ on patient quality of life measured by lifestyle questionnaire 'Impact of Weight on Quality of Life-Lite' (IWQOL-Lite).

    Measured: Up to 6 months post-placement

  2. Safety of the TransPyloric Shuttle™ (TPS™)

    Preliminary evidence of TPS™ safety measured by device-related and procedure-related adverse events.

    Measured: Up to 6 months post-placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMar 2012
  4. Study completionMay 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01386905
Sponsor's protocol ID
TPSS-I-0409-B
Status last verified
Mar 2014
First submitted
30 Jun 2011
Last updated
12 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9620907

  • 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.

    PubMed 15329183

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

Questions about this trial

What is this clinical trial studying?

A study testing BAROnova™ TransPyloric Shuttle™ (TPS™) in people with Obesity, run by BaroNova, Inc. at 1 site in Australia.

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 13 inclusion and 34 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of the TransPyloric Shuttle™ System (TPS™) (time frame: Up to 6 months post-placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01386905, which also lists 3 linked publications.

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 12 Mar 2014.

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