Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

HSC-MS-15-0668


NCT ID:

NCT02589171


Secondary ID:


Study Acronym:


Brief Title:

The neoClose Abdominal Closure vs Carter-Thomason Trial


Official Title:

Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas Health Science Center, Houston


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Actual


Overall Contact Information

Official Name:Shinil Shah, MD
Principal Investigator
The University of Texas Health Science Center, Houston

Study Dates

Start Date:February 12, 2016
Completion Date:April 25, 2018
Completion Type:Actual
Primary Completion Date:April 25, 2018
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 17, 2019
First Received Date:October 20, 2015
First Results Date:July 26, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site
Time Frame:at the time of surgery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site
Time Frame:at the time of surgery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site
Time Frame:at the time of surgery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site
Time Frame:at the time of surgery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site
Time Frame:at the time of surgery
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Time Frame:immediately post op
Safety Issues:False
Description:Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Time Frame:1 week
Safety Issues:False
Description:Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively
Time Frame:6 weeks
Safety Issues:False
Description:Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.
Outcome Type:Primary Outcome
Measure:Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively
Time Frame:6 weeks
Safety Issues:False
Description:Abdominal ultrasound will be used to detect port site hernia.
Outcome Type:Secondary Outcome
Measure:Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Time Frame:day 1
Safety Issues:False
Description:Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Outcome Type:Secondary Outcome
Measure:Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Time Frame:1 week
Safety Issues:False
Description:Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Outcome Type:Secondary Outcome
Measure:Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale
Time Frame:6 weeks
Safety Issues:False
Description:Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Outcome Type:Secondary Outcome
Measure:Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Time Frame:day 1
Safety Issues:False
Description:Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Outcome Type:Secondary Outcome
Measure:Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Time Frame:1 week
Safety Issues:False
Description:Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Outcome Type:Secondary Outcome
Measure:Pain at the Stapler Port Site as Assessed by a Visual Analog Scale
Time Frame:6 weeks
Safety Issues:False
Description:Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.
Outcome Type:Secondary Outcome
Measure:Pain as Assessed by Number of Participants Who Took Pain Medications
Time Frame:week 1
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pain as Assessed by Number of Participants Who Took Pain Medications
Time Frame:week 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Hospital Stay Duration
Time Frame:from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Neo Close Abdominal Closure
Description:Neo Close Abdominal Closure
Arm Name:Neo Close Abdominal Closure
Intervention Type:Device
Name:Carter Thomason Device
Description:Carter Thomason Device
Arm Name:Carter Thomason Device

Study Arms

Study Arm Type:Active Comparator
Arm Name:Carter Thomason Device
Study Arm Type:Experimental
Arm Name:Neo Close Abdominal Closure

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas Health Science Center, Houston
Agency Class:Industry
Agency Type:Collaborator
Agency Name:NeoSurgical Limited

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.