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CompletedNCT01026103Updated Mar 14, 2014Results posted

Tri Staple Technology Stapler Used in Gastric Bypass

An interventional study of Tri Staple Technology stapler in Sleep Apnea, Hypertension and Hyperlipidemia, sponsored by Medtronic - MITG. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-14.

Sponsored by Medtronic - MITG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Apnea
  • Hypertension
  • Hyperlipidemia
  • Coronary Artery Disease
  • Gastroesophageal Reflux Disease
  • Osteoarthritis
  • Diabetes

Keywords

  • gastric bypass
  • Gastric bypass surgery
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 28 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Tri Staple

    This is a single arm study.

    Device: Tri Staple Technology stapler

Interventions

  • DeviceTri Staple Technology stapler

    This is a single arm study.

06

What researchers measure

Primary outcomes

  1. Proportion of Patients With an Uneventful Creation of a Functional Staple Line

    Time frame: Day 0

Secondary outcomes

  1. Incidence of Intra-operative Bleeding Requiring Intervention

    Time frame: Day 0 and 1 month

  2. Length of Hospital Stay

    Time frame: Date of discharge which averages 3 days

  3. Incidence of Serosal Tearing

    Time frame: 30 days post op

07

Results

Posted Mar 14, 2014

Participant flow

Participant flow — Overall Study
MilestoneTri Staple
Started30
Consented30
Completed28
Not completed2
Withdrew: Physician decision1
Withdrew: Did not receive study device bc of error1

Outcome measures

PrimaryProportion of Patients With an Uneventful Creation of a Functional Staple Line
Time frame:
Day 0
Reported as:
Number · participants
Proportion of Patients With an Uneventful Creation of a Functional Staple Line
participantsTri Staple
Proportion of Patients With an Uneventful Creation of a Functional Staple Line28 (88 to 100)
SecondaryIncidence of Intra-operative Bleeding Requiring Intervention
Time frame:
Day 0 and 1 month
Reported as:
Number · participants
Incidence of Intra-operative Bleeding Requiring Intervention
participantsTri Staple
Incidence of Intra-operative Bleeding Requiring Intervention19 (48 to 84)
SecondaryLength of Hospital Stay
Time frame:
Date of discharge which averages 3 days
Reported as:
Mean · days
Length of Hospital Stay
daysTri Staple
Length of Hospital Stay3.2 ± 0.5
SecondaryIncidence of Serosal Tearing
Time frame:
30 days post op
Reported as:
Number · participants
Incidence of Serosal Tearing
participantsTri Staple
Incidence of Serosal Tearing0

Adverse events

Collected over 30 days post surgery. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tri Staple—2/28 (7.1%)24/28 (85.7%)
Most frequent serious events
Most frequent serious events
EventTri Staple
StrictureGastrointestinal disorders2/28
GI BleedGastrointestinal disorders1/28
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTri Staple
FatigueGeneral disorders19/28
ConstipationGastrointestinal disorders18/28
NauseaGeneral disorders14/28
PainSurgical and medical procedures10/28
DepressionPsychiatric disorders7/28
VomittingGeneral disorders6/28
EdemaSkin and subcutaneous tissue disorders3/28
InfectionInfections and infestations3/28
BloatingGastrointestinal disorders2/28
Blood LossSurgical and medical procedures2/28

Baseline characteristics

30 patients consented; 1 patient was withdrawn by physician for elevated liver function test. Twenty-nine (29) patients had baseline characteristics but 1 did not receive study device in error leaving 28 patients enrolled.

Age, Continuous
Age, Continuous(years)Tri Staple
Mean42.2 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)Tri Staple
Female24
Male5
Region of Enrollment
Region of Enrollment(participants)Tri Staple
United States29
08

Study locations

1 site
  • Clarian Bariatric Center/Indiana University
    Indianapolis, Indiana 46202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01026103
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Dec 4, 2009
Start date
Jan 2010
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Mar 14, 2014
Last update
Mar 14, 2014

Study contacts

Samer G Mattar, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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