Tri Staple Technology Stapler Used in Gastric Bypass

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Medtronic

Status

Completed

Conditions

Coronary Artery Disease
Hypertension
Diabetes
Osteoarthritis
Hyperlipidemia
Gastroesophageal Reflux Disease
Sleep Apnea

Treatments

Device: Tri Staple Technology stapler

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026103
AS09004

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Tri Staple
Experimental group
Description:
This is a single arm study.
Treatment:
Device: Tri Staple Technology stapler

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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