ObesityITALYIIINCT01024465
ReShape Intragastric Balloon for the Treatment of Obesity
A study testing ReShape Duo Balloon in people with Obesity, run by ReShape Lifesciences at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ReShape Duo Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Casa di Cura Solatrix
Rovereto, 38068
Regional Hospital
Vicenza, 36100
About this study
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).
- Conditions
- Obesity
- Being tested
- ReShape Duo Balloon
- Keywords
- obesity, intragastric balloon
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReShape Duo BalloonDevice
ReShape Duo Balloon
| Study group | Role | What they receive |
|---|---|---|
| ReShape Duo Balloon | Experimental | Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon Receives: Device: ReShape Duo Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Weight Loss
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Measured: baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReShape Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY, Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
- Responsible party
- Sponsor
- Investigators
- Mary Lou Mooney, Study director, ReShape Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024465
- Sponsor's protocol ID
- 2009-1
- Acronym
- ITALYIII
- Status last verified
- Sep 2015
- First submitted
- 25 Nov 2009
- Last updated
- 29 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReShape Intragastric Balloon for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT01024465
- Acronym / sponsor ID
- ITALYIII / 2009-1
- Conditions
- Obesity
- Keywords
- obesity, intragastric balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ReShape LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY, Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 11 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReShape Duo Balloon | Experimental | Device: ReShape Duo BalloonPatients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReShape Duo BalloonReShape Duo Balloon | Device | ReShape Duo Balloon |
Primary outcome
Total Weight Loss
Time frame: baseline to 180 days
Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Lou Mooney study director
ReShape Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReShape Duo Balloon in people with Obesity, run by ReShape Lifesciences at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Weight Loss (time frame: baseline to 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.