Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy

NCT01632202 | Terminated Phase 4 Results DMC

• 1 other identifier: AAAF2293
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place. When used in the abdominopelvic cavity, it has been shown to reduce the incidence of adhesions. The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon itself in the normal state. It has been demonstrated that the trauma of removing a submucosal fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions since the raw charred surface is directly opposed to the opposite endometrial surface. Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity after a myomectomy is not only safe, but also decreases the incidence of intrauterine adhesions. The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that they will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, the investigators anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.

Conditions

Intrauterine Adhesions

Keywords

submucosal myomas; intrauterine adhesions; hysteroscopic myomectomy; seprafilm

Outcome Measures

Primary Outcomes (1)

• Presence of Iatrogenic Intrauterine Adhesions

  Number of Subjects with iatrogenic intrauterine adhesions. Evidence of uterine scarring will be evaluated by a 3D sonohysterogram. A 3D sonohysterogram will be performed in the standard fashion in our ultrasound department by a blinded practitioner. The degree of adhesive disease will be scored by standard convention as: * Absent Adhesive Disease: no presence of intrauterine adhesions * Mild Adhesive Disease: cavities that are less than or equal to 30% affected * Moderate Adhesive Disease: cavities that are greater than 30% but less than or equal to 60% affected * Severe Adhesive Disease: cavities that are greater than 60% affected

  2- 3 months after surgery

Secondary Outcomes (1)

• Pregnancy Within 12 Months of Treatment

  Up to 12 months after surgery

Study Arms (2)

Seprafilm Slurry

ACTIVE COMPARATOR

The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that we will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, we anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.

Device: Seprafilm

Placebo

PLACEBO COMPARATOR

For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.

Device: Sterile Saline Solution

Interventions

Seprafilm DEVICE

Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC).

Seprafilm Slurry

Sterile Saline Solution DEVICE

For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.

Placebo

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Reproductive aged women: Age 18-48 years old
• Non-pregnant
• Otherwise healthy
• Regular menstrual cycle
• Documented submucosal myomas (one or more)
• Undergoing hysteroscopic myomectomy
• Patients must have signed an informed consent.

You may not qualify if:

• Age \< 18 or in menopause
• Undergoing a second uterine surgical procedure
• Other significant uterine pathology (including but not limited to adhesions, septae, or cancerous lesions)
• Hysteroscopic evidence of synechiae at the time of the procedure
• Surgeries complicated by excessive bleeding; defined by estimated blood loss \> 100cc given that the presence of excessive bleeding may predispose a patient to the formation of intrauterine adhesions
• Surgeries complicated by uterine perforation
• Surgeries complicated by postoperative intrauterine infection given that infection may predispose a patient to the formation of intrauterine adhesions (If these patients received Seprafilm Slurry, they will continue to be followed for safety monitoring)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (2)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Sr. Research Compliance Specialist
• Organization: Weill Cornell Medicine

lao2003@med.cornell.edu

646-962-4065

Study Officials

• Rogerio A Lobo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 2, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Locations

US (2)