A Prospective, Controlled, Randomized, Multi-Center, Phase I/II Study Evaluating the Safety and Efficacy of Adhexil™ - Using Adhexil To Prevent and/or Reduce Adhesions After Ovarian Surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1.Female patients aged 18-45 years at screening
2.Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease
3.Patients must be willing to participate in the study, and provide written informed consent
4.Patient available and willing to undertake study visits and procedures
5.Patients of child-bearing potential must be using a medically acceptable method of birth control throughout the study.
6.Presence of both ovaries and both intact fallopian tubes.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant (including ectopic pregnancy) or breastfeeding patients
2.Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation
3.Patients whose 1LL procedure would involve surgical sterilization
4.Patients whose 1LL procedure would involve hysterectomy
5.Patients with a documented diagnosis of cancer
6.Patients with a lymphatic, hematologic or coagulation disorder
7.Known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™
8.Patients whose pre-operative laboratory values at the baseline visit are out of normal ranges
9.Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
10.Patients who have participated in another clinical study within 30 days of enrolment.
11.Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study
12.Patients with American Society of Anesthesiologists class > I

Intra-Operative Exclusion Criteria
1.Failure to lyse any of the existing ovarian adhesions
2.Absence of one or both ovaries
3.Absence of one or both Fallopian tubes
4.Presence of active infection.
5.Presence of malignancy
6.Use of heparin-containing irrigants
7.Use of other adjuvants for the purpose of reducing adhesions, including INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex, corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents.
8.Requirement to perform enterotomy and/or cystotomy and/or urostomy and/or hysterectomy
9.Patients who underwent a peritoneal grafting procedure
10.Patients in whom a procedure required conversion to laparotomy
11.Use of any topical hemostatic agents that are left behind in the body or use of catgut, chromic catgut, or nonresorbable sutures on the ovaries or immediately adjacent structures
12.Use of gasless laparoscopy
13.Performance of non-gynecologic surgical procedure (cholecystectomy)
14.Investigator’s opinion that a second look is not in the best interest of the patient

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluate the safety and initial efficacy of the anti-adhesion kit (AA) AdhexilTM for the prevention and/or reduction of prospective adhesions in female patients who are undergoing a surgical procedure involving the ovaries.;Secondary Objective: There are no secondary objectives for this study.;Primary end point(s): The primary endpoint will be the incidence of ovaries with adhesions.

Secondary Outcome Measures

Name	Time	Method

Related Trials