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Surgical Device

Tri Staple for Coronary Artery Disease

N/A
Waitlist Available
Led By Samer G Mattar, MD
Research Sponsored by Medtronic - MITG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post op
Awards & highlights

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.

Eligible Conditions
  • Coronary Artery Disease
  • Sleep Apnea
  • High Blood Pressure
  • Acid Reflux
  • Osteoarthritis
  • Diabetes
  • High Cholesterol

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Incidence of Serosal Tearing
Length of Hospital Stay

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tri StapleExperimental Treatment1 Intervention
This is a single arm study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tri Staple Technology stapler
2010
N/A
~30

Find a Location

Who is running the clinical trial?

Medtronic - MITGLead Sponsor
255 Previous Clinical Trials
300,879 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
235 Patients Enrolled for Coronary Artery Disease
Samer G Mattar, MDPrincipal InvestigatorIndiana University
~2 spots leftby Jul 2025
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