Tri Staple Technology Stapler Used in Gastric Bypass

Hypertension Clinical Trial

Official title:

A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026103
• Other study ID #: AS09004
• Status: Completed
• Phase: N/A
• First received: December 3, 2009
• Last updated: January 29, 2014
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: January 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 to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

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 one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.

• 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 requiring mesh repair

• The patient has a history of clinically significant liver disease

• The patient has a history of drug or alcohol abuse within 2 years of enrollment

• The patient has a history of venous thrombosis or pulmonary embolism

• The patient has a history of coagulopathy

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Myocardial Ischemia
• Osteoarthritis
• Sleep Apnea

Intervention

Device:
• Tri Staple Technology stapler
This is a single arm study.

Locations

Country	Name	City	State
United States	Clarian Bariatric Center/Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With an Uneventful Creation of a Functional Staple Line		Day 0	No
Secondary	Incidence of Intra-operative Bleeding Requiring Intervention		Day 0 and 1 month	No
Secondary	Length of Hospital Stay		Date of discharge which averages 3 days	No
Secondary	Incidence of Serosal Tearing		30 days post op	No