|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 9, 2008 | ||||
| Last Updated Date | July 14, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Document successful gastric plication using reduction gastroplasty [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Gastric plication [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00721227 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates | ||||
| Official Title ICMJE | Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates | ||||
| Brief Summary | This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention. |
||||
| Detailed Description | The overall plan for all subjects consists of the following elements:
|
||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Procedure: Reduction Gastroplasty | ||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 15 | ||||
| Estimated Completion Date | January 2010 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
Exclusion Criteria: Subjects will be excluded from the study for any of the following:
|
||||
| Gender | Both | ||||
| Ages | 21 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00721227 | ||||
| Responsible Party | Amy Mahanes, Ethicon Endo-Surgery | ||||
| Study ID Numbers ICMJE | CI-07-0005 | ||||
| Study Sponsor ICMJE | Ethicon Endo-Surgery | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Ethicon Endo-Surgery | ||||
| Verification Date | July 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||