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Tri Staple Technology Stapler Used in Gastric Bypass

This study has been completed.
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT01026103
First received: December 3, 2009
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Sleep Apnea
Hypertension
Hyperlipidemia
Coronary Artery Disease
Gastroesophageal Reflux Disease
Osteoarthritis
Diabetes
 Device: Tri Staple Technology stapler

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:
  • The primary measures of performance and safety will be the proportion of patients with an uneventful creation of a functional staple line and the 30 day cumulative incidence of adverse events respectively. [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimations of the incidence of intra-operative bleeding requiring intervention, length of stay, and the incidence of serosal tearing along the staple line will be secondary objectives. [ Time Frame: intra-operative and 1 month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tri Staple
This is a single arm study.
 Device: Tri Staple Technology stapler
This is a single arm study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026103

Locations
United States, Indiana
Clarian Bariatric Center/Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Samer G Mattar, MD Indiana University
  More Information

No publications provided

Responsible Party: Stephanie Marcucio, Clinical Research Associate II, Covidien
ClinicalTrials.gov Identifier: NCT01026103     History of Changes
Other Study ID Numbers: AS09004
Study First Received: December 3, 2009
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
gastric bypass
Gastric bypass surgery

Additional relevant MeSH terms:
Apnea
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Gastroesophageal Reflux
Hyperlipidemias
Hypertension
Osteoarthritis
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013