Ignite Creation Date:
2025-12-17 @ 8:10 PM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT00721227
Status:
None
Last Update Posted:
2010-09-08 00:00:00
First Post:
2008-07-09 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Sponsor:
None
Organization:
Study Overview
Official Title:
Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
Status:
None
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall plan for all subjects consists of the following elements:
* Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).
* Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.
* Subjects are followed for 12 months to evaluate outcomes and potential complications.
* Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).
* Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.
* Subjects are followed for 12 months to evaluate outcomes and potential complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: