A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
Public ClinicalTrials.gov record NCT01673698. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
Study identification
- NCT ID
- NCT01673698
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 326 participants
Conditions and interventions
Conditions
Interventions
- ReShape Duo balloon Device
- Diet counseling Other
- Exercise counseling Other
Device · Other
Eligibility (public fields only)
- Age range
- 21 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2012
- Primary completion
- Mar 31, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Dec 6, 2015
2012 – 2014
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | — |
| Hamilton Medical Center | Dalton | Georgia | 30720 | — |
| Marquette General Surgical Weight Loss Center | Marquette | Michigan | 49855 | — |
| University of Minnesota/Department of Gastrointestinal Surgery | Minneapolis | Minnesota | 55455 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| Greenville Hospital System | Simpsonville | South Carolina | 29680 | — |
| Midsouth Bariatrics | Memphis | Tennessee | 38120 | — |
| University of TX Health Science Center at Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01673698, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 6, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01673698 live on ClinicalTrials.gov.