Safety and Efficacy Study of Duet TRS

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00950872
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Roux En Y Gastric Bypass	Device: Duet TRS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duet TRS Subjects receive Duet TRS	Device: Duet TRS; Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events. [Day 30]

Secondary Outcome Measures

1. Operating Room (OR) Time [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 [Day 2 (Approximately 1.5 days post randomization)]

   Days spent in the hospital

3. Incidence of Stapler 'Misfires' [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Health System	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Aurora Pryor, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT00950872
• Other Study ID Numbers: AS08016
• First Posted: Aug 3, 2009
• Last Update Posted: May 1, 2014
• Last Verified: Mar 1, 2014

Study Results

Participant Flow

Recruitment Details	Between November 24, 2009 and March 29, 2010, a total of 29 patients were consented and screened for potential study participation at one institution (Duke University). Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
Pre-assignment Detail	Subjects were evaluated for pre-operative and intra-operative eligibility criteria prior to enrollment.

Arm/Group Title	Duet TRS
Arm/Group Description	Duet TRS is a staple line buttress
Period Title: Overall Study
STARTED	29
COMPLETED	26
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Duet TRS
Arm/Group Description	Subjects receive Duet TRS Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.2 (11.3)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	24 82.8%
Male	5 17.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 31%
White	17 58.6%
More than one race	0 0%
Unknown or Not Reported	3 10.3%
Region of Enrollment (participants) [Number]
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Events.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Arm/Group Title	Duet TRS
Arm/Group Description	Duet TRS is a staple line buttress
Measure Participants	27
Number [adverse events]	6

2. Secondary Outcome

Title	Operating Room (OR) Time
Description	OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Arm/Group Title	Duet TRS
Arm/Group Description	Duet TRS is a staple line buttress
Measure Participants	27
Mean (Standard Deviation) [minutes]	98 (27)

3. Secondary Outcome

Title	Length of Hospital Stay
Description	Days spent in the hospital
Time Frame	Day 2 (Approximately 1.5 days post randomization)

Outcome Measure Data

Analysis Population Description

Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Arm/Group Title	Duet TRS
Arm/Group Description	Duet TRS is a staple line buttress
Measure Participants	27
Mean (Standard Deviation) [days]	1.5 (0.6)

4. Secondary Outcome

Title	Incidence of Stapler 'Misfires'
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.

Arm/Group Title	Duet TRS
Arm/Group Description	Duet TRS is a staple line buttress
Measure Participants	27
Number [participants]	3 10.3%

Adverse Events

Time Frame	1 month
Arm/Group Title	Duet TRS
Arm/Group Description	Duet TRS is a staple line buttress
All Cause Mortality
	Duet TRS
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Duet TRS
	Affected / at Risk (%)	# Events
Total	2/27 (7.4%)
Gastrointestinal disorders
Gastrojejunal Anatomosis Stricture	2/27 (7.4%)	2
Other (Not Including Serious) Adverse Events
	Duet TRS
	Affected / at Risk (%)	# Events
Total	0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.