Phase
Condition
N/ATreatment
Zip-stitch(R)
Reference suture
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provision of signed and dated Informed Consent Form 2. Stated willingness to complywith all study procedures, including participation in follow-up visits andtelephonic follow-up 3. Female 18 years and older 5. Indicated for LaparoscopicHysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic AssistedVaginal Hysterectomy, or robotic assisted vaginal hysterectomy)
Exclusion
Exclusion Criteria:
History of Human Immunodeficiency Virus (HIV)
History of Hepatitis C
History of diabetes that, in the opinion of the investigator, may delay healing
Current use of systemic corticosteroids
Active infection of genitals, vagina, cervix, uterus or urinary tract
Active bacteremia, sepsis or other active systemic infection
Presence of Sexually Transmitted Infection (STI)
Evidence of pelvic inflammatory disease (PID)
Known clotting defects or bleeding disorders
Hemoglobin < 8 g/dL
Metastatic disease
On anticoagulant therapy
Participation in another interventional trial
Pregnancy
Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or inthe opinion of the investigator may indicate abnormal vaginal cuff healing
Co-morbidities that, in the opinion of the investigator, may indicate risk ofabnormal vaginal cuff healing
Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior toattempted cuff closure
Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior toattempted cuff closure
Intra-operative: Cases in which surgeon cannot identify adequate tissue along thecuff to apply suture laparoscopically
Intra-operative: Cases requiring conversion to laparotomy prior to studyintervention
Study Design
Study Description
Connect with a study center
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Unified Women's Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Lankenau Hospital
Wynnewood, Pennsylvania 19096
United StatesSite Not Available
Tidewater Clinical Research
Virginia Beach, Virginia 23456
United StatesSite Not Available
Mon Health Medical Center
Morgantown, West Virginia 26505
United StatesSite Not Available
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