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| Name | Class |
|---|---|
| Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY | UNKNOWN |
| Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY | UNKNOWN |
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A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within their labeled indications and as per their instructions for use. Enrolled patients will be followed for seven months. The patient will be prescribed a controlled diet, exercise and counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReShape Duo Balloon | Experimental | Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReShape Duo Balloon | Device | ReShape Duo Balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Weight Loss | Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up. | baseline to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Lou Mooney | ReShape Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa di Cura Solatrix | Rovereto | 38068 | Italy | |||
| Regional Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | ReShape Duo Balloon | Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were enrolled who met the study's inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | ReShape Duo Balloon | Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Weight Loss | Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up. | Subjects with a weight recorded at 6 months | Posted | Mean | Standard Deviation | kg | baseline to 180 days |
|
|
180 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ReShape Duo Balloon | Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon ReShape Duo Balloon: ReShape Duo Balloon |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea/vomiting after discharge | Gastrointestinal disorders | verbatim | Systematic Assessment |
No limitations nor caveats apply.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | ReShape Medical | 949-429-6680 | lfong@reshapemedical.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Vicenza |
| 36100 |
| Italy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 26 |
| 16 |
| 26 |
| gastric bloating | Gastrointestinal disorders | verbatim | Systematic Assessment |
|
| epigastric pain | Gastrointestinal disorders | verbatim | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | verbatim | Systematic Assessment |
|
| ulcer at removal | Gastrointestinal disorders | verbatim | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | verbatim | Systematic Assessment |
|
Upon study conclusion, the PI has the right to use the study data for educational purposes, scientific conferences and publications. The sponsor will have a period of 15 days (for abstracts) and 30 days (for scientific publications) to review the proposal for disclosure / publication for the sole purpose of protecting any confidential information. If such disclosure contains Confidential Information, the PI agrees to remove such Confidential Information.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |