(RESTORe) Clinical trial Incisionless TX for Pts W/ Inadequate Wt Loss Following RnY...

jamiecatlady5
on 1/28/08 6:39 pm - UPSTATE, NY

Someone was inquiring into this I can not recall where? From looks of things the study is closed? (See here: http://www.obesityhelp.com/forums/revision/a,messageboard/ac tion,replies/board_id,5360/cat_id,4960/topic_id,3512658/ )

http://clinicaltrials.gov/ct2/show/NCT00394212?recr=open&int r=%22gastric+bypass%22&rank=21 Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass This study is currently recruiting participants. Verified by C. R. Bard, October 2007

Sponsored by:

C. R. Bard

Information provided by:

C. R. Bard

ClinicalTrials.gov Identifier:

NCT00394212

Purpose

It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating.

For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass.

The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.

Condition

Intervention

Phase

Obesity

Device: Transoral Suturing

Phase III

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:

Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction (RESTORe) for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass Surgery

Further study details as provided by C. R. Bard:

Primary Outcome Measures:

· Weight Loss [ Time Frame: 6 months ]

Secondary Outcome Measures:

· Excess Weight Lost (EWL) [ Time Frame: 6 months ]

· Weight Stabilization [ Time Frame: 6 months ]

· Improvement in Comorbidities and Quality of Life Parameters [ Time Frame: 6 months ]

Estimated Enrollment:

230

Study Start Date:

November 2006

Estimated Study Completion Date:

July 2008

Arms

Assigned Interventions

1: Experimental

transoral suturing

Device: Transoral Suturing

suturing of anastomosis

2: Sham Comparator

suturing not performed

Device: Transoral Suturing

suturing of anastomosis

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

· 6 months post primary RYGB with inadequate weight loss or weight regain

· BMI >30 and ≤ 50

· Dilated gastrojejunal anastomosis

· Successfully completes screening process

· Signed consent

Exclusion Criteria:

· Recently quit smoking or plan to quit within the next year

· Pregnant or planning to become pregnant over the course of the next 9 months

· Mallampati score of 4

· Serious systemic disease or active disease of the gastrointestinal tract

· Gastric pouch abnormalities

· Significant movement limitations

· Use of weight-promoting or weight-reduction drugs during study period

· Severe eating disorders

· Uncontrolled depression or psychoses

· Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure

· History of significant cardiovascular, cerebrovascular or pulmonary disease

· Not a candidate for conscious or general sedation

· Anticoagulant therapies

· Active substance abuse

· Life expectancy < 1 year

· Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394212 Contacts

Contact: Email Only

000-000-0000

[email protected]

Locations

Take Care,

Jamie Ellis RN MS NPP
100cm proximal Lap RNY 10/9/02 Dr. Singh Albany, NY
320(preop)/163(lowest)/185(current) 5'9'' (lost 45# before surgery)
Plastics 6/9/04 & 11/11/2005 Dr. King www.albanyplasticsurgeons.com
http://www.obesityhelp.com/member/jamiecatlady5/
"Being happy doesn't mean everything's perfect, it just means you've decided to see beyond the imperfections!"

Amy C.
on 1/28/08 7:58 pm - Old Chatham, NY

RNY on 05/02/06

Gosh this is an uphill battle, isn't it? Whoever thought food and eating could hold so many people in its grips (me, being top on the list)? So darned hard!

Thanks for posting!

xo
A

Open RNY 05/02/06 with Dr. Carl Rosati, Albany Medical Center
301/170/goal 160? Abdominoplasty on 8/21/07 with Dr. Jerome Chao, Albany Medical Center

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