Safety and Efficacy Study of Duet TRS

NCT00950872 | Completed Results

• 1 other identifier: AS08016
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.

Conditions

Roux En Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events.

  Day 30

Secondary Outcomes (3)

• Operating Room (OR) Time

  Day 0

• Length of Hospital Stay

  Day 2 (Approximately 1.5 days post randomization)

• Incidence of Stapler 'Misfires'

  Day 0

Study Arms (1)

Duet TRS

EXPERIMENTAL

Subjects receive Duet TRS

Device: Duet TRS

Interventions

Duet TRS DEVICE

Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.

Duet TRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be 18-65 years of age.
• The patient has a BMI of 40-60 kg/m2 or 35-40 kg/m2 with comorbidities
• The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

You may not qualify if:

• The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
• The patient is pregnant.
• The patient has an active, or history of, infection at the operative site.
• The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
• Patient has an abdominal ventral hernia
• The patient has a history of liver disease
• The patient has a history of drug or alcohol abuse
• The patient has a history of venous thrombosis or pulmonary embolism
• The patient has a history of coagulopathy

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Noreen Fahey, Director, Clinical Program Management
• Organization: Covidien

noreen.fahey@covidien.com

203-821-4716

Study Officials

• Aurora Pryor, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 3, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 1, 2014
• Results First Posted: May 1, 2014

Record last verified: 2014-03

Locations

US (1)