NCT01026103

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

December 3, 2009

Results QC Date

January 29, 2014

Last Update Submit

January 29, 2014

Conditions

Sleep ApneaHypertensionHyperlipidemiaCoronary Artery DiseaseGastroesophageal Reflux DiseaseOsteoarthritisDiabetes

Keywords

gastric bypassGastric bypass surgery

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With an Uneventful Creation of a Functional Staple Line

    Day 0

Secondary Outcomes (3)

  • Incidence of Intra-operative Bleeding Requiring Intervention

    Day 0 and 1 month

  • Length of Hospital Stay

    Date of discharge which averages 3 days

  • Incidence of Serosal Tearing

    30 days post op

Study Arms (1)

Tri Staple

EXPERIMENTAL

This is a single arm study.

Device: Tri Staple Technology stapler

Interventions

Tri Staple Technology staplerDEVICE

This is a single arm study.

Tri Staple

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarian Bariatric Center/Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHypertensionHyperlipidemiasCoronary Artery DiseaseGastroesophageal RefluxOsteoarthritisDiabetes Mellitus

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Results Point of Contact

Title
Noreen Fahey
Organization
Covidien
noreen.fahey@covidien.com
203-821-4716

Study Officials

  • Samer G Mattar, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 14, 2014

Results First Posted

March 14, 2014

Record last verified: 2014-01

Locations

US(1)