Gastric Plication and Banding | NCT02072395

Studies
Gastric Plication and Banding

NCT02072395

Sponsor

Ohio State University

Status

Completed

Last Update Posted

Feb 20, 2017Actual

Enrollment

17Actual

Phase

Phase 2

Conditions

Morbid Obesity

Interventions

Plication

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Feb 24, 2014

First Posted Date

Feb 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2017

Last Update Posted Date

Feb 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Band/Plication	Experimental	Treatment -- band/plication	Procedure: Plication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plication	Procedure	Plication of the stomach will be performed in conjunction with placement of a gastric band.	Band/Plication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss	The primary endpoint is weight loss two years post-surgery.	Two years
Complications	Intra and post-operative complications will be tracked.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70
BMI > or = to 30 and co-morbid conditions or BMI > or = to 40
Ability to provide informed consent
Willingness to commit to long-term follow-up

Exclusion Criteria:

Inability to provide informed consent
Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi
Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion
Pregnancy
Plan to become pregnant within two years post-surgery
Current addiction to drugs or alcohol
Previous history of any type of bariatric surgery (de novo group only)
Hiatal hernia > 3 cm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bradley J Needleman, MD	Ohio State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Wexner Medical Center		Columbus	Ohio	43210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25443058	Background	Chaudhry UI, Osayi SN, Suzo AJ, Noria SF, Mikami DJ, Needleman BJ. Laparoscopic adjustable gastric banded plication: case-matched study from a single U.S. center. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):119-24. doi: 10.1016/j.soard.2014.05.030. Epub 2014 Jun 4.

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders