Skip to main content
OpenTrials
Completed

NCT Number: NCT01026103

Tri Staple Technology Stapler Used in Gastric Bypass

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Apnea Arterial Occlusive Diseases Arteriosclerosis Arthritis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Deglutition Disorders Diabetes Diabetes Mellitus Digestive System Diseases Dyslipidemias Dyssomnias Endocrine System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Glucose Metabolism Disorders Heart Diseases Hyperlipidemia Hyperlipidemias Hypertension Joint Diseases Lipid Metabolism Disorders Metabolic Diseases Musculoskeletal Diseases Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Osteoarthritis Respiration Disorders Respiratory Tract Diseases Rheumatic Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clarian Bariatric Center/Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tri Staple Technology stapler

Device

This is a single arm study.

Primary outcomes

  1. Proportion of Patients With an Uneventful Creation of a Functional Staple Line

    Time frame: Day 0

Secondary outcomes

  1. Incidence of Intra-operative Bleeding Requiring Intervention

    Time frame: Day 0 and 1 month

  2. Length of Hospital Stay

    Time frame: Date of discharge which averages 3 days

  3. Incidence of Serosal Tearing

    Time frame: 30 days post op

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.