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Completed

NCT Number: NCT00950872

Safety and Efficacy Study of Duet TRS

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.

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Key information

Conditions

Roux En Y Gastric Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, 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 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

Treatment and study plan

Duet TRS

Device

Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.

Primary outcomes

  1. Incidence of Adverse Events.

    Time frame: Day 30

Secondary outcomes

  1. Operating Room (OR) Time

    Time frame: Day 0

    OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.

  2. Length of Hospital Stay

    Time frame: Day 2 (Approximately 1.5 days post randomization)

    Days spent in the hospital

  3. Incidence of Stapler 'Misfires'

    Time frame: Day 0

    The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.

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 Staplers With ENDO GIA Single Use Loading Units With DUET TRS TM in a Gastric Bypass Procedure

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 3, 2009
Registry last updated
May 1, 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.

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