- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00679848
Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM)
January 9, 2017 updated by: C. R. Bard
Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity
The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male, Female; ages >18yrs - £ 60 yrs
- BMI 30-45 kg/m2
- History of obesity for 5 yrs; attempts at weight control ineffective
- Weight stable
- Willing to comply with study requirements
- Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure
- Sign informed consent form
Exclusion Criteria:
- Women of childbearing age not practicing effective birth control method or pregnant or lactating
- Mallampati score = 4
- Uncontrolled hypothyroidism
- Previous interventional/surgical treatment of obesity; any prior gastric surgery
- History of diabetes for > 10 yrs or difficult to control diabetes
- Presence of hiatal hernia
- Congenital or acquired anomalies of the GI tract
- Severe cardiovascular, cerebrovascular, or cardiopulmonary disease
- Chronic or acute upper gastrointestinal bleeding conditions
- Helicobacter pylori positive
- Immunocompromised
- Subjects with eating disorders
- Acute or chronic infection
- Significant movement limitations
- Not a candidate for conscious or general anesthesia
- Active substance abuse
- Life expectancy < 2 years
- Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Transoral Suturing
|
Suturing in stomach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight Loss
Time Frame: 24 Months
|
24 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Technical success of test procedure.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
May 13, 2008
First Submitted That Met QC Criteria
May 15, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DVL-EC-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on RS2 (RESTORe Suturing System)
-
Istituto Auxologico ItalianoRecruiting
-
Ethicon Endo-SurgeryCompleted
-
Brigham and Women's HospitalApollo Endosurgery, Inc.CompletedObesity | Overweight | Body WeightUnited States
-
University Hospitals Cleveland Medical CenterApollo Endosurgery, Inc.CompletedColon Malignant Tumor | Colon Benign TumorUnited States
-
University Medical Centre MariborCompletedPostoperative Complications | Local Anesthesia | Achilles Tendon Rupture | Percutaneous RepairSlovenia
-
Lawson Health Research InstituteNot yet recruitingBreast Cancer | Gynecomastia | Transgenderism | Breast Asymmetry
-
University Health Network, TorontoRyerson UniversityRecruitingPTSD | Anxiety | Depressive Symptoms | Mental HealthCanada
-
University Health Network, TorontoCanadian Department of Defence; University Health Network FoundationCompletedPTSD | Anxiety | Depressive Symptoms | Mental HealthCanada
-
Centre Hospitalier Universitaire de NīmesRecruitingWounds, NonpenetratingFrance