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The neoClose Abdominal Closure vs Carter-Thomason Trial

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Surgical Port Site Hernia

Treatments

Device: Carter Thomason Device
Device: Neo Close Abdominal Closure

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02589171
HSC-MS-15-0668

Details and patient eligibility

About

The purpose of this study is to compare the neoClose abdominal closure to the standard Carter-Thomason closure in a bariatric surgery gastric bypass population.

Full description

Both the neoClose abdominal closure to the standard Carter-Thomason closure will be used to close 12 mm camera port sites and 12 mm stapler port sites upon completion of a robotic assisted laparoscopic gastric bypass. The procedure requires a 12 mm port site be placed in the midline approximately 3 cm cephalad to the umbilicus and a second 12mm port site in the right mid abdomen. Port sites will be closed as defined as the inability to palpate a fascial defect and the incision being air tight upon carbon dioxide insufflation.

Enrollment

70 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Morbid obesity (BMI > 35).
  • Completed multimodality pre operative evaluation (Psychology, Nutrition, Support Groups).
  • Approved for robotic assisted laparoscopic gastric bypass.

Exclusion criteria

  • Previous midline laparotomy or weight loss procedure.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups

Neo Close Abdominal Closure
Experimental group
Treatment:
Device: Neo Close Abdominal Closure
Carter Thomason Device
Active Comparator group
Treatment:
Device: Carter Thomason Device

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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