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The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass.
Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TORe and Lifestyle Modification Arm | Active Comparator | Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study |
|
| Lifestyle Modification Arm | Active Comparator | Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORe with OverStitch | Device | Transoral Outlet Reduction with OverStitch Endoscopic Suturing System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Weight Loss | The percent TBWL that subjects achieve at 6 months post-randomization | 6 Months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant weight loss | The rate of subjects that achieve clinically significant weight loss (i.e. responders) at 6 months. Clinically significant weight loss is defined as ≥ 10% TBWL. | 6, 12 and 24 months post enrollment |
| Percent TBWL at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Lazzari | Contact | 508-561-7296 | victoria.lazzari@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital | Recruiting | Irvine | California | 92618 | United States |
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| Intensive lifestyle modification | Behavioral | Intensive lifestyle modification program consists of the following: well-balanced calorie-restrictive diet, incorporation of exercise and coaching on lifestyle changes. The program should include personal discussions and goals designed and overseen by the treating physician, obesity management professional or dietician. |
|
Percent TBWL at each visit |
| 6 months post enrollment and through end of study |
| Change in A1C | Change in Hemoglobin A1C from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Insulin | Change in Insulin from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Fasting Glucose | Change in Fasting Glucose from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Cholesterol | Change in Total Cholesterol from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in LDL | Change in LDL from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in HDL | Change in HDL from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Triglycerides | Change in Triglycerides from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Alanine transaminase (ALT) | Change in ALT from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Alkaline phosphatase (ALP) | Change in ALP from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Aspartate aminotransferase (AST) | Change in AST from baseline | 6, 12, 18, and 24 months post enrollment |
| Reduction in Medications for Type 2 diabetes | Reduction in Type 2 diabetes medication dose and frequency from Baseline | 6, 12, 18 and 24 months post enrollment |
| Reduction in Hypertension Medication | Reduction in hypertension medication dose and frequency from Baseline | 6, 12, 18 and 24 months post enrollment |
| Reduction in cholesterol medication | Reduction in cholesterol medication dose and frequency from Baseline | 6, 12, 18 and 24 months post enrollment |
| Reduction in medications for dumping syndrome | Reduction in dumping syndrome medication dose and frequency from Baseline | 6, 12, 18 and 24 months post enrollment |
| Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Continuous assessment of safety of TORe by summarizing the occurrence of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) at all visits and overall. | From enrollment through 24 months (study completion) |
| Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire | Change in IWQOL LITE-CT scores from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire | Change in SF-36 Questionnaire scores from baseline | 6, 12, 18, and 24 months post enrollment |
| Change in Sigstad Score | Change in Sigstad score from baseline | 6, 12, 18, and 24 months post enrollment |
| Stanford University Medical Center | Not yet recruiting | Stanford | California | 94305 | United States |
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| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Orlando Health Inc | Recruiting | Orlando | Florida | 32806 | United States |
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| University of South Florida | Not yet recruiting | Tampa | Florida | 33606 | United States |
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| Rush University Medical Center | Not yet recruiting | Chicago | Illinois | 60612 | United States |
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| Mayo Clinic Foundation | Recruiting | Rochester | Minnesota | 55905 | United States |
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| NYU Grossman School of Medicine | Not yet recruiting | New York | New York | 10016 | United States |
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| University of Texas Houston Health Science Center | Not yet recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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