Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00762905
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for a laparoscopic surgical procedure
* Aged 18 years or older
* Agree to return to 2-weeks (3 days) post-procedure follow-up visit
* Agree to return to 3-month (5 days) post-procedure follow-up visit
* Able and willing to give informed consent and to comply with all study requirements
Exclusion Criteria:
* Known sensitivity to cyanoacrylate, formaldehyde or acetone products,
* Surgical procedures involving mucus membranes or eyes
* History of skin rashes or exfoliative condition at time of procedure
* History of keloid formation or hypertrophy
* Currently on immunosuppressive therapy
* Decubitus ulcer
* Pregnant or nursing.
* Participated in an investigational drug or device study within the past 3 months
* Conditions known to interfere with wound healing:
* Diabetes, Type I or II
* Advanced chronic renal insufficiency (GFR greater than 25 mL/min or with clinical signs of azotemia), uremia or endstage renal disease
* Advanced liver failure or cirrhosis (Child-Pugh score of B or C)
* Advanced malignancy, or cancer patients currently receiving chemotherapy (within 30 days of procedure)
* History of radiation therapy to the study area
* Advanced COPD (FEV greater than 1 litre and or PaO2 60 mmHg)
* Suspected infection at incision site
* Peripheral vascular disease
* Corticosteroid therapy
* Morbid obesity (50-100 percent or 100 pounds above their ideal body weight and/or a BMI value greater than 40)
* Blood clotting disorders (e.g. Haemophilia)
* Wounds under high tension forces (over joints)
* Life expectancy of greater than 3 months
* ASA level of 4 or 5
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00762905
Study Brief:
Protocol Section:
NCT00762905