A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MetaCure (USA), Inc.
ClinicalTrials.gov Identifier:
NCT00779363
First received: October 23, 2008
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

The objectives of this feasibility study are to evaluate the safety and functionality of the TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on trends of HbA1c, blood glucose and body weight changes.


Condition Intervention
Type 2 Diabetes
Obesity
Device: rechargeable TANTALUS II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial of the TANTALUS System In Treatment of Obese to Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by MetaCure (USA), Inc.:

Primary Outcome Measures:
  • Safety Evaluation [ Time Frame: June 2004-September2009 ] [ Designated as safety issue: Yes ]
  • Device Functionality Evaluation [ Time Frame: June 2004-September2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c [ Time Frame: June 2004-September2009 ] [ Designated as safety issue: No ]
  • Percentage of body weight loss [ Time Frame: June 2004-September2009 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implanted Device Device: rechargeable TANTALUS II
Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.

Detailed Description:

This is a prospective multi center, non-randomized, treatment only clinical trial with up to thirty (30) obese with type 2 diabetes subjects. The study is designed to demonstrate that use of the rechargeable TANTALUS II IPG is safe and that it functions as designed.

Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21-70 years
  • Diabetic subjects having HbA1c greater than or equal to 7.5% and less than or equal to 9.5 % at Visit 1
  • Sex: male or female. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
  • Type 2 diabetes duration less than 10 years but at least 6 months
  • Type 2 diabetic Subjects taking no more than two (2) oral anti-diabetic agents [Sulfonylurea, Metformin or thiazolinedione (TZD)].
  • Stable anti-diabetic drugs for at least three (3) months prior to enrollment and six (6) months for thiazolinedione (TZD).
  • Fasting blood glucose values > 120 and < 240 mg/dl at baseline
  • Stable HbA1c, described as no significant change (≤ 0.5% variation) between a historical value in the subjects' medical record within 3 months prior to enrollment and the A1c value gathered at baseline.
  • If subject is under anti-depressant medication, the treatment needs to be stable for at least six (6) months prior to enrollment.
  • BMI between 28 and 45 (kg/m2)
  • Stable weight, defined as no significant weight change over the three months prior to enrollment as reported by the subject (±5 kg).
  • Stable medications (including anti-hypertensive and lipid-lowering) for at least one month prior to enrollment.
  • Compliant, willing and able to participate in the follow-up visits for the study duration.
  • Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial.
  • Able to provide voluntary informed consent.

Exclusion Criteria:

  • Gastroparesis or intestinal pseudo-obstruction.
  • Receiving medications known to affect gastric motility.
  • Taking appetite suppressant or weight loss medications within 1 month of enrollment.
  • Diabetic subjects on insulin.
  • Past or current psychiatric condition that may impair his or her ability to comply with the study procedures.
  • Severe eating disorders such as bulimia or binge eating.
  • Obese due to a clinically diagnosed endocrine problem.
  • Pregnant (proven by positive βhCG), or lactating.
  • History of anemia (<10 g/dl) over past 3-months.
  • Prior bariatric surgery.
  • History of peptic ulcer disease.
  • Use of another investigational device or agent in the 30 days prior to enrollment.
  • Participation in another clinical study.
  • Life threatening co-morbidity or life expectancy of less than one year.
  • Myocardial Infarction or one or more episodes of unstable angina within six months prior to enrollment.
  • Implanted with a permanent pacemaker, an automatic implantable defibrillator, or other electro-stimulation device.
  • History of life threatening disease within 5 years of enrollment.
  • Use of routine ulcerogenic drugs.
  • Use of prescription, over the counter or herbal weight loss products.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779363

Locations
United States, California
Cedars Sinai
Los Angeles, California, United States, 90048
United States, Texas
Diabetes and Glandular Disease Clinic (DGD)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
MetaCure (USA), Inc.
Investigators
Study Chair: Harold Lebowitz, MD Proffesor of Medicine, Endocrinology and Metabolism/Diabetes, State University on NY Health Science
  More Information

No publications provided

Responsible Party: MetaCure (USA), Inc.
ClinicalTrials.gov Identifier: NCT00779363     History of Changes
Other Study ID Numbers: MC CR TAN2007-012
Study First Received: October 23, 2008
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MetaCure (USA), Inc.:
obese,
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014