Back to resultsTri Staple Technology Stapler Used in Gastric Bypass
Primary Purpose
Sleep Apnea, Hypertension, Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tri Staple Technology stapler
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring gastric bypass, Gastric bypass surgery
Eligibility Criteria
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
Sites / Locations
- Clarian Bariatric Center/Indiana University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tri Staple
Arm Description
This is a single arm study.
Outcomes
Primary Outcome Measures
Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Secondary Outcome Measures
Incidence of Intra-operative Bleeding Requiring Intervention
Length of Hospital Stay
Incidence of Serosal Tearing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01026103
Brief Title
Tri Staple Technology Stapler Used in Gastric Bypass
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis, Diabetes
Keywords
gastric bypass, Gastric bypass surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tri Staple
Arm Type
Experimental
Arm Description
This is a single arm study.
Intervention Type
Device
Intervention Name(s)
Tri Staple Technology stapler
Intervention Description
This is a single arm study.
Primary Outcome Measure Information:
Title
Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Incidence of Intra-operative Bleeding Requiring Intervention
Time Frame
Day 0 and 1 month
Title
Length of Hospital Stay
Time Frame
Date of discharge which averages 3 days
Title
Incidence of Serosal Tearing
Time Frame
30 days post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer G Mattar, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clarian Bariatric Center/Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
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Tri Staple Technology Stapler Used in Gastric Bypass
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