Trial Outcomes & Findings for Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy (NCT NCT01632202)
NCT ID: NCT01632202
Last Updated: 2020-12-03
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
2- 3 months after surgery
Results posted on
2020-12-03
Participant Flow
11 signed a consent form, but only 8 were randomized.
Participant milestones
| Measure |
Seprafilm Slurry
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.
Seprafilm: 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).
|
Placebo
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
7
|
|
Overall Study
COMPLETED
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
Baseline characteristics by cohort
| Measure |
Seprafilm Slurry
n=1 Participants
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.
Seprafilm: 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).
|
Placebo
n=7 Participants
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2- 3 months after surgeryPopulation: Only 5 out of the 8 enrolled completed the 3D sonohysterograms and therefore were the only ones included in the data analysis for the primary outcome measure.
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
Outcome measures
| Measure |
Seprafilm Slurry
n=1 Participants
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.
Seprafilm: 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).
|
Placebo
n=4 Participants
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
|
|---|---|---|
|
Presence of Iatrogenic Intrauterine Adhesions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after surgeryPopulation: Only 3 out of the 8 randomized completed the fertility follow up. There were 2 subjects (1 in the treatment arm and 1 in the placebo arm) who were not actively trying to get pregnant, and therefore did not complete the fertility follow up.
Number of pregnancies within 12 months of treatment. In order to determine if Seprafilm helps improve pregnancy rates we will be conducting an additional follow-up phone call up to 12 months from the day of sonohysterogram. In women who have wished to get pregnant we will ask if they have been trying to get pregnant and if they have gotten pregnant. Participation in this follow up call is optional.
Outcome measures
| Measure |
Seprafilm Slurry
n=1 Participants
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.
Seprafilm: 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).
|
Placebo
n=2 Participants
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
|
|---|---|---|
|
Pregnancy Within 12 Months of Treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Seprafilm Slurry
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Seprafilm Slurry
n=1 participants at risk
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.
Seprafilm: 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).
|
Placebo
n=7 participants at risk
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
Sterile Saline Solution: For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
|
|---|---|---|
|
General disorders
Fever
|
100.0%
1/1 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
14.3%
1/7 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
100.0%
1/1 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
0.00%
0/7 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
|
General disorders
Pelvic Pain
|
0.00%
0/1 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
42.9%
3/7 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
|
Reproductive system and breast disorders
Uterine Cramps
|
100.0%
1/1 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
71.4%
5/7 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
|
Reproductive system and breast disorders
Vaginal Bleeding
|
0.00%
0/1 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
85.7%
6/7 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
100.0%
1/1 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
100.0%
7/7 • Post-operative Day 1, Post-operative Day 7, and Post-operative Day 30
|
Additional Information
Sr. Research Compliance Specialist
Weill Cornell Medicine
Phone: 646-962-4065
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place