Obesity
Conditions
Keywords
obesity, intragastric balloon
Brief summary
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).
Interventions
DEVICEReShape Duo Balloon
ReShape Duo Balloon
Sponsors
Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY
Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
ReShape Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* The patient is male or female between the ages of 20 and 60 years of age. * The patient presents with a Body Mass Index (BMI) 30-40 kg/m2. * The patient is geographically stable and willing to return to the implant center for follow-up visits. * The patient has been adequately informed of risks and requirements and consents to his/her participation in the post market clinical study.
Exclusion criteria
* The patient presents with 20 years \> Age \> 60 years. * The patient has a progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months. * The patient is a pregnant or lactating female. * The patient presents with a 30 kg/m2 \> BMI \> 40 kg/m2. * The patient has had previous abdominal surgery. * The patient has digestive tract disorders such as active peptic ulcers, bleeding disorders, esophageal varices, Crohn's disease. * The patient presents with psychiatric disorders. * The patient is participating in concomitant research studies of investigational products that would interfere with this study. * The patient has inability to return for follow-up assessments. * The patient is an alcohol or drug abuser.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Weight Loss | baseline to 180 days | Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | ReShape Duo Balloon |
|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Total Weight Loss
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Time frame: baseline to 180 days
Population: Subjects with a weight recorded at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ReShape Duo Balloon | Total Weight Loss | -9.4 kg | Standard Deviation 6.3 |