N/A
N=30
Tri Staple Technology Stapler Used in Gastric Bypass
Sleep Apnea · Hypertension · Hyperlipidemia · Coronary Artery Disease · Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT01026103 ↗Enrolled (actual)
30
Serious AEs
7.1%
Results posted
Mar 2014
Primary outcome: Primary: Proportion of Patients With an Uneventful Creation of a Functional Staple Line — 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tri Staple Technology stapler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With an Uneventful Creation of a Functional Staple Line |
28 | — |
| SECONDARY Incidence of Intra-operative Bleeding Requiring Intervention |
19 | — |
| SECONDARY Length of Hospital Stay |
3.2 | — |
| SECONDARY Incidence of Serosal Tearing |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01026103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.