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.

Burlington, Massachusetts 01805


Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.

Study summary:

Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.


Inclusion Criteria: - Patient must comply with follow-up evaluations - Patient or representative must provide informed consent prior to enrollment - Patient scheduled for elective surgical excision of the left, anterior or low anterior colon - Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location Exclusion Criteria: - Crohns disease - Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis. - Patients who have not had mechanical bowel preparation - Patients with known documented sensitivity/allergy to bovine material - Severe radiation damage to tissue - Carcinomatosis or stage IV cancer - BMI is 35 or greater - Cancer at primary anastomosis site that cannot be excised - Patients who require an ileo rectal anastomosis - Surgery anticipated to include jejunostomy pouch - Anticipated diverting stoma - No anti adhesive barrier can be used around anastomotic site - No multiple circular anastomosis - Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis - Patient life expectacny less than follow-up timeframe of study - Pregnancy - Patients currently enrolled in a study that competes for the same patient population



Primary Contact:

Principal Investigator
Richard Karulf, MD
Colon & Rectal Surgery Associates

Backup Contact:


Location Contact:

Burlington, Massachusetts 01805
United States

There is no listed contact information for this specific location.

Site Status: N/A

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.

Click to view Full Listing

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