N/A
Completed N=29
Safety and Efficacy Study of Duet TRS
Roux En Y Gastric Bypass
Source: ClinicalTrials.gov NCT00950872 ↗
Enrolled (actual)
29
Serious AEs
7.4%
Results posted
May 2014
Primary outcomePrimary: Incidence of Adverse Events. — 6 adverse events
Summary
The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events. |
6 | — |
| SECONDARY Operating Room (OR) Time |
98 | — |
| SECONDARY Length of Hospital Stay |
1.5 | — |
| SECONDARY Incidence of Stapler 'Misfires' |
3 | — |
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 comorbidities
- 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
- The patient has a history of liver disease
- The patient has a history of drug or alcohol abuse
- The patient has a history of venous thrombosis or pulmonary embolism
- The patient has a history of coagulopathy
Data sourced from ClinicalTrials.gov (NCT00950872). 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. Informational only — not medical advice.