Safety and Efficacy Study of Duet TRS

Roux En Y Gastric Bypass Clinical Trial

Official title:

A Prospective, Single-Center Investigation of the Safety and Performance of the ENDO GIA Staplers With ENDO GIA Single Use Loading Units With DUET TRS TM in a Gastric Bypass Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950872
• Other study ID #: AS08016
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: March 31, 2014
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Roux En Y Gastric Bypass

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events.		Day 30	No
Secondary	Operating Room (OR) Time	OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.	Day 0	No
Secondary	Length of Hospital Stay	Days spent in the hospital	Day 2 (Approximately 1.5 days post randomization)	No
Secondary	Incidence of Stapler 'Misfires'	The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.	Day 0	No