Randomized Trial Evaluating Effectiveness of neoClose Abdominal Closure Device Versus Carter-Thomason Needle Passer
Phase: NA
Conditions: Surgical Port Site Hernia
Sponsor: The University of Texas Health Science Center, Houston

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
 
 
 
 
 
 
 
 
Randomized Trial Evaluating Effectiveness of neoClose®Abdominal Closure Device 
versus Carter-Thomason® Needle Passer 
 
NCT02589171 
 
Version Date: 03/02/2017 
 
 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
Randomized Trial Evaluating Effectiveness of neoClose®Abdominal Closure Device versus 
Carter- Thomason® Needle Passer 
 
 
Peter Walker MD 
Shinil Shah DO 
Erik Wilson MD 
 
Version 6 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
SYNOPSIS 
 
Study Title 
Randomized Trial Evaluating Effectiveness of neoClose® Abdominal Closure 
Device versus CarterThomason® Needle Passer 
Trial Design 
A randomized trial intended to compare neoClose® abdominal closure versus 
standard Carter- Thomason® closure in a bariatric surgery gastric bypass and 
sleeve gastrectomy population. The primary objective of the study is to compare 
the technical effectiveness of the devices.  A secondary outcome will be analysis 
of pain scores associated with the distinct closures. 
The study will be by a group of 6 Bariatric / General Surgeons at a high volume 
academic institution. Patients will be randomized upon induction of anesthesia 
and blinded to the closure technique performed. Video analysis of technical 
effectiveness will be performed as well as clinic follow up at 1 week ,6 weeks and 
1 year after the procedure to assess pain scores. In addition, an abdominal 
ultrasound will be completed at 6 weeks and 1 year to evaluate the incidence of 
port site hernia. 
Procedure 
Both devices will be used to close 12 mm camera and stapler port sites upon 
completion of a robotic assisted laparoscopic gastric bypass and sleeve 
gastrectomy. The procedure requires a 12 mm port be placed in the midline 
approximately 3 cm cephalad to the umbilicus and a second in the right mid 
abdomen. Port sites will be closed as defined as the inability to palpate a fascial 
defect . 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
Study Population Adults aged 18-70 years with BMI > 35 that have completed a multimodality 
bariatric workup (EGD, nutrition evaluation and psychological evaluation) and 
selected to have an elective gastric bypass and sleeve gastrectomy. 
Subjects who fail to complete extensive pre-operative work up including 
endoscopic surveillance, nutrition visit, psychological clearance will be excluded 
from the study. A pregnancy test will be done on female subjects as part of 
Standard of care. 
There will be 35 patients per group. A power analysis was completed using the 
data derived from our preclinical porcine study using primary endpoint of time 
(32 seconds for Carter- Thomason® and 18.5 seconds for neoClose®). The alpha 
utilized was 0.05.  A total of 70 patients will be screened for the study. 
Assessments 
The study will allow for the evaluation of technical effectiveness and analysis of 
pain scoring: 
Technical Effectiveness 
 Number of sutures required to complete closure. 
 Time required to complete closure. 
 Depth of needle penetration to complete closure. 
 Evaluate for surgical site occurrences immediately post op as well as at 1 
,6 weeks and 1 year after closure procdure. 
 Evaluation for port site hernia at 6 weeks with abdominal ultrasound. 
Pain Evaluation 
 Visual analog pain scale will be used to assess pain at both port sites. 
 Amount of intravenous narcotics required during hospitalization. 
 Hospital stay duration. 
The study will allow for assessment of pain scores during hospitalization and at 
follow up visits approximately 1 week ,6 weeks and 1 year. 
Data Collection 
During the procedure, an independent examiner will record the amount of time 
and number of suture passes to obtain port site closure. In addition, an 
independent review of video from each procedure will be completed to record 
the time and depth of needle exposure. Patients will fill out pain analog scores 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
during hospital stay and follow up visits. Care givers on the floor and in clinic will 
be blinded to the closure technique. 
Hospital records will be reviewed to record narcotic requirements. 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
 
Principal Investigators 
 
Peter Walker MD 
Assistant Professor of Surgery 
University of Texas Health Sciences Center at Houston 
6431 Fannin Street, MSB 4.294 
Houston TX 77030 
Peter.A.Walker@uth.tmc.edu 
Office 713-500-7277 
Fax 713-383-3708 
 
Shinil Shah DO 
Assistant Professor of Surgery 
University of Texas Health Sciences Center at Houston 
6431 Fannin Street, MSB 4.294 
Houston TX 77030 
Office 713-500-7277 
Fax 713-383-3708 
 
Erik B Wilson MD 
Professor of Surgery 
Vice Chairman Department of Surgery 
University of Texas Health Sciences Center at Houston 
6431 Fannin Street, MSB 4.294 
Houston TX 77030 
Office 713-500-7277 
Fax 713-383-3708 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
 
Co Investigators 
Brad Snyder MD 
Associate Professor of Surgery 
University of Texas Health Sciences Center at Houston 
 
Shelindra Mehta MD 
Assistant Professor of Surgery 
University of Texas Health Sciences Center at Houston 
 
Kulvinder Bajwa MD 
Assistant Professor of Surgery 
University of Texas Health Sciences Center at Houston 

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IRB NUMBER: HSC-MS-15-0668 
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A. RATIONALE 
Laparoscopic surgery requires the utilization of multiple ports with varying diameters. In the 
bariatric population, gastric bypass and sleeve gastrectomy requires 12 mm port placement for 
camera and stapler insertion. Many surgeons favor closure of the fascial defect in order to 
decrease the risk of hernia occurrence. Various type of port closure is available.  The most 
popular closure device is the Carter-Thomason® needle.  This device has inherent limitations: 
 
(1) Insertion of the needle is associated with injury to the viscera and blood vessels. 
(2) The width of the suture placed using the Carter-Thomason® needle can lead to compression 
of peritoneum and entrapment of underlying nerves, causing post-operative port site pain. 
(3) Placement of the suture is challenging in the obese patient. (1) 
 
Very few studies have been completed to compare novel devices to the Carter- Thomason® with 
equivocal data. (2)(3) 
Current practice requires fascial closure with a suture passing needle which passes the suture 
material through some amount of subcutaneous tissue, muscle, and fascia.  This technique is 
often associated with elevated levels of discomfort which can remain weeks after the operation is 
complete. In addition, the technique of port site closure can be difficult to learn leading to 
prolonged times potential needle exposure to underlying viscera as well as times for port site 
closure. 
The development of a novel closure device which relies upon the guided deployment of 
suture / fasteners could help improve the learning curve associated with port site closure. In 
addition, such a technique that would not require passage of suture material through adjacent 
muscle and isolated the posterior fascia could lead to an improvement in patient satisfaction 
secondary to a decrease in pain. 
The neoClose ® device is an abdominal closure device that has been approved by the FDA in 
2013 (510K) to use as such.  The study aims to add to the existing knowledge about these kinds 
of devices and also to evaluate the effectiveness of the neoClose® device compared to the Carter- 
Thomason® device. Moreover, surveys will also be administered to patients using the Visual 
Analog Scale of pain to establish pain scores associated with individual closures. 
 
B. STUDY DESIGN AND PROCEDURE 
 
Patient Allocation 
 
This is a randomized study consisting of 35 patients. This site will be the only site across the US 
doing the study.  On the morning of the procedure,  qualified subjects who were consented for 
the study will be randomized to fascial closure with either the neoClose® device or a Carter- 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
Thomason® suture passer. The floor team and the subjects will be blinded to the closure 
technique. 
 
 
Small Pouch Gastric Bypass 
Our model will include patients having robotic assisted gastric bypass. Briefly, the procedure 
involves the placement of 6 total trocars.  Two large trocars (12 mm port placed 3 cm cephalad 
to the umbilicus and a 12 mm port in the right mid clavicular line) undergo fascial closure at the 
completion of the case.  The dissection is started by making a small proximal gastric pouch with 
a linear stapler.  A hand sewn gastrojejunostomy is then created approximately 50 cm distal to 
the ligament of Treitz.  The small intestine is divided and then a 150 cm roux limb is created and 
a small bowel anastomosis is completed. No local anesthetic will be utilized in the study patients 
in order to avoid compounding variable to the assessment of pain scores. 
 
Sleeve Gastrectomy 
Patients having robotic assited sleeve gasterectomy will also be in the study. For this 
procedure, the same number of trocers and same locations will utilized. The stomach is 
visualized and fully mobilized. Sleeve gastrectomy is achieved with a linear stapler. The 
stomach is removed from the 15- mm port site in the right upper quadrant. Similar to the 
gastric bypass study patients, local anesthesia will not be used to avoid compounding 
variable in pain assessment. 
 
 
Port Site Closure 
Either the neoClose® device with provided suture/fasteners or a Carter- Thomason® suture passer 
with 0 Vicryl will be used to close the port sites.  The port sites will be considered closed when 
no fascial defect can be palpated. 
 
Data Collection 
An autonomous recorder will document the number of sutures required to close each port site as 
well as the time required to obtain closure during the procedure. A video will be created of each 
procedure followed by careful analysis of the film by an independent reviewer to record the time 
of needle exposure to the abdominal cavity as well as depth of needle passage. 
 
Each patient will be placed upon a Dilaudid pain pump immediately after the procedure and 
transitioned to oral narcotics upon initiation of liquid diet. Analog pain scoring will be 
completed on each hospital day as well as clinic visits approximately 1 ,6 weeks and 1 year after 
the operation. In addition, after patient discharge, the amount of narcotics required during 
hospitalization will be recorded. An abdominal ultrasound will be completed at 6 weeks and 1 
year after the operation to evaluate the incidence of trocar site hernias. 
 
The data will be stored on a password protected UT supplied computer in Excel files by MRN 
and without names. Upon analysis of the data, the MRN will be deleted thereby erasing all 
potential patient identifiers. 

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IRB NUMBER: HSC-MS-15-0668 
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Data Analysis 
 
Data will be analyzed using a simple T test within the Excel program as there will be only two 
groups with a single variable between them. Post Hoc analysis will not be required as with 
ANOVA secondary to the lack of a third group. 
 
C. DEVICE USE AND TRAINING 
Instructions for Use 
A description of the neoClose® system and its components, intended use, technical details, 
warnings, precautions, and procedural steps will be provided to all users in the Instructions for 
Use. To operate the system, the operator must read the IFU and be fully trained and acquainted 
with the operation and function of each part of the system. To demonstrate the ease of product 
utilization, no prior large animal training will be required. 
 
D. STUDY OBJECTIVES 
Primary Outcome Measure 
To compare technical effectiveness of neoClose® device versus classic Carter- Thomason® 
suture passer.  This will completed by comparing: 
 
 Time required to complete port closure. 
 Number of sutures required to complete port closure. 
 Time needle is within abdominal cavity. 
 Depth of needle into the abdominal cavity. 
 Evaluation of surgical site occurrences. 
 Evaluation of trocar site hernia incidence with abdominal ultrasound. 
Secondary Outcome Measures 
 Comparison of perioperative and post operative pain via visual analog scoring while in 
the hospital and at follow up appointments 2 ,6 weeks and 1 year after discharge. 
 Comparison of narcotic requirements during hospitalization. 
 Comparison of hospital stay duration. 
E. STUDY GUIDELINES 
Patient Population 
Subjects will be patients aged 18-70 that have been evaluated by a multimodality team including 
a surgeon, nutritionist, and psychiatrist then scheduled for a robotic assisted gastric bypass and 

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IRB NUMBER: HSC-MS-15-0668 
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sleeve gastrectomy. Once surgery has been approved patient will be considered for the study if 
they have no prior history of midline laparotomy and are having a de novo gastric operation. 
 
F. CLINICAL EVENTS 
 
Risks 
 
Risks to the patient are the same as the baseline procedure with Carter- Thomason® - visceral 
injury, hematoma, hernia, pain. There is no foreseeable additional risk when using the 
neoClose® device over the baseline treatment. 
 
Adverse Events (AEs) 
AEs clinically relevant to the patient will be recorded from the perioperative period through the 
sick week follow up period. 
The following is a non-comprehensive list of possible adverse events: 
 Hematoma or bleeding at port site. 
 Iatrogenic visceral injury during port closure. 
 Seroma at port site. 
 SSI at port site. 
 
G. ETHICAL AND REGULATORY CONSIDERATIONS 
Confidentiality 
Data that will be gathered for the study will be de-identified to protect patient information. 
Research charts and video recordings would be stored in a room under lock and key. No 
identifying markers would be included in the video recording of subjects in the study. Only the 
PI and designated staff would have access to the charts and video recordings. The video 
recordings will be kept for a maximum of 3 months to give ample time for review and analysis. 
The video recording will then be disposed in a  manner that is according to UTHealth policy. 
Electronic security measures would also be taken. These are all done to minimize the inherent 
risk of breach of confidentiality. 
 
Informed Consent 
 
The background, purpose and potential risks and benefits of the proposed study will be explained 
to each subject under the care of the investigator. Subjects will be informed of their right to 
withdraw from the study at any time and for any reason without sanction, penalty, or loss of 
benefits to which the subject is otherwise entitled, and that withdrawal from the registry will not 
jeopardize their future medical care. 

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IRB NUMBER: HSC-MS-15-0668 
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References 
1. Shetty A, Adiyat K. Comparison between hand suture and Carter-Thomason® needle 
closure of port sites in laparoscopy.  Urology J. 2014;11:1768-71. 
 
2. Del Junco M, Okhunov Z, Juncal S, Yoon R, Landman J. Evaluation of a novel trocar- 
site closure and comparison with a standard Carter-Thomason® closure device. J 
Endourol. 2014;28:814-818. 
 
3. Guan X, Zurawin RK. Comparison of neat Stitch and Carter-Thomason® Trocar Port 
Closure Techniques.  J Min Invasive  Gynecology. 2011;19:175. 

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IRB NUMBER: HSC-MS-15-0668 
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APPENDIX 1 
 
Post Operation Data Form (Day1) 
 
Study ID: 
Date: 
Date of Surgery: 
Duration of Surgery (min): 
No. of sutures to complete suture: 
Duration to complete closure: 
Length of Hospital Stay: 
 
Pain Medication (in Hospital) and dosage:  
 
Pain Evaluation: 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
 

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IRB NUMBER: HSC-MS-15-0668 
IRB APPROVAL DATE: 03/02/2017 
 
Follow-up Visit Data Form 
 
Study ID: 
Date: 
Date of Surgery: 
Follow up visit no. : 
 
 
Pain Medication and dosage:  
 
Pain Evaluation: 
 
 
 
Notes: