Status:
COMPLETED
Screened Health Assessment & Pacer Evaluation
Lead Sponsor:
University of Pennsylvania
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System in a population of patients with a BMI between 35 and 55.
Detailed Description
The purpose of this study is to evaluate efficacy and safety of the Transneuronix IGS System in a population of patients with a BMI between 35 and 55. Initially, a maximum of 150 patients will be foll...
Eligibility Criteria
Inclusion
- 1\) Ability to give informed consent 2) 18 to 65 years of age at time of screening 3) BMI of 35 to 55 at time of screening 4) Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragms, IUDs, or condoms with or without spermicide, and voluntary abstinence. The method of birth control must be documented and verified at follow-up.
- 5\) Patients with a reported history of five years of obesity (BMI \> 30) 6) Patients who require pharmacological therapy for psychological disorders, either at study entry or after implant, must obtain a letter from a licensed psychologist/psychiatrist justifying the use of the medication for psychological reasons only (Appendix D).
- 7\) Patients must agree to follow the dietary component of the protocol as outlined in Appendix A and attend monthly support group meetings (Appendix E).
- 8\) Patients must be geographically stable and reside within a 2-hour commute from the clinical site (as determined by the investigator or study coordinator) and be able and willing to travel to the clinical site for all follow-up visits and monthly support group meetings.
Exclusion
- 1\) Patients who are excluded by the screening algorithm18, 19, 22 (Appendix C) 2) Patients scoring 29 or higher on the Binge Eating Scale Questionnaire (Appendix F) 3) Patients will undergo a psychological evaluation by a licensed psychologist or psychiatrist (Appendix D). Patients who are substance abusers or are identified as having borderline personality, bipolar disorder, or any other disorder that would make them inappropriate candidates, in the opinion of the psychologist/psychiatrist.
- 4\) Pregnant or lactating females 5) Prior surgery of GI tract as therapy for obesity 6) Prior surgery on the stomach for any reason 7) Other electrical stimulation devices 8) Patients with known history or under treatment for ulcers 9) Patients with a clinically significant hiatal hernia 10) Patients with motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation 11) Patients taking any weight loss medication or other drugs that can affect body weight (e.g. mirtazapine, laxatives, systemic glucocorticoids, neuroleptic agents, progestational steroids) within three months prior to screening 12) Patients who require continuous therapy with known ulcerogenic medication (e.g., aspirin, non-steroidal anti-inflammatory agents, COX-2 inhibitors) 13) Patients with a history of cardiac arrhythmia or severe cardiac disease (NYHA class III or IV) 14) Type I diabetes and poorly controlled Type II diabetes as evidenced by an HbA1c level greater than 10%. Those patients with an HbA1c between 8% and 10% and who have ongoing symptoms of hyperglycemia, including unexplained weight loss or significant polyuria, polydipsia, or a fasting glucose level above 180 mg/dl\* within 5 days prior to implantation, will be excluded.
- \* If the fasting glucose level is above 180 mg/dl during screening, the patient will not be excluded from the study but be treated for hyperglycemia. Laboratory tests, including a fasting glucose level, will be repeated for all patients within 5 days prior to implantation.
- 15\) Any diabetic patients on non-steady treatment with thiazolidinediones (Actos or Avandia) within past three months prior to screening 16) Patients with a history of Barrett's esophagus 17) Patients who have severe weight-related co-morbid diseases that require immediate weight loss (e.g., life-threatening sleep apnea) 18) Patients with any serious health condition not related to their weight 19) Use of another investigational agent within 30 days prior to screening 20) Patients whom the investigator or study coordinator considers to be unable or unwilling to fulfill study requirements
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00312611
Start Date
August 1 2004
End Date
August 1 2006
Last Update
March 30 2017
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