Intrauterine AdhesionsPhase 4SeprafilmNCT01632202
Seprafilm Slurry in the Prevention of Uterine Scarring in Patients Undergoing Hysteroscopic Myomectomy
A Phase 4 study testing Seprafilm and Sterile Saline Solution in people with Intrauterine Adhesions, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Adhesions
- What is being tested?
- Seprafilm and Sterile Saline Solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Weill Medical College of Cornell University
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy
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.
Read the detailed description
The investigators will conduct a randomized controlled trial (RCT) involving patients at NewYork Presbyterian Hospital-Columbia University Medical Center and Weill Medical College of Cornell University. The investigators will enroll 328 pre- menopausal patients (>18years) with documented submucosal myomas undergoing hysteroscopic myomectomy with monopolar resection in this study.
The investigators anticipate that approximately 30% of the patients undergoing myomectomy will form intrauterine adhesions and that administration of the Seprafilm slurry will reduce the incidence to approximately 15%.
Patients will be queried on post-operative days 1, 7, and 30 for pain/discomfort and the degree of intrauterine adhesions will be assessed after the patient's second menses (75-90 days post procedure).
- Conditions
- Intrauterine Adhesions
- Being tested
- Seprafilm, Sterile Saline Solution
- Keywords
- submucosal myomas, intrauterine adhesions, hysteroscopic myomectomy, seprafilm
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprafilmDevice
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).
Sterile Saline SolutionDevice
For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Seprafilm |
| Placebo | Placebo comparator | For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline. Receives: Device: Sterile Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2- 3 months after surgery
Secondary outcomes (1)
Pregnancy Within 12 Months of Treatment
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.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: No subjects were recruited at the Weill Cornell site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intrauterine AdhesionsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Rogerio A Lobo, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632202
- Sponsor's protocol ID
- AAAF2293
- Acronym
- Seprafilm
- Status last verified
- Nov 2020
- First submitted
- 28 Jun 2012
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Seprafilm Bioresorbable Slurry in the Prevention of Intrauterine Synechiae in Patients Undergoing Hysteroscopic Myomectomy
- ClinicalTrials.gov ID
- NCT01632202
- Acronym / sponsor ID
- Seprafilm / AAAF2293
- Conditions
- Intrauterine Adhesions
- Keywords
- submucosal myomas, intrauterine adhesions, hysteroscopic myomectomy, seprafilm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No subjects were recruited at the Weill Cornell site.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- May 2012 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Jul 2012 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct a randomized controlled trial (RCT) involving patients at NewYork Presbyterian Hospital-Columbia University Medical Center and Weill Medical College of Cornell University. The investigators will enroll 328 pre- menopausal patients (>18years) with documented submucosal myomas undergoing hysteroscopic myomectomy with monopolar resection in this study.
The investigators anticipate that approximately 30% of the patients undergoing myomectomy will form intrauterine adhesions and that administration of the Seprafilm slurry will reduce the incidence to approximately 15%.
Patients will be queried on post-operative days 1, 7, and 30 for pain/discomfort and the degree of intrauterine adhesions will be assessed after the patient's second menses (75-90 days post procedure).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seprafilm Slurry | Active comparator | Device: SeprafilmThe 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. |
| Placebo | Placebo comparator | Device: Sterile Saline SolutionFor those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Reproductive aged women: Age 18-48 years old
- Non-pregnant
- Otherwise healthy
- Regular menstrual cycle
- Documented submucosal myomas (one or more)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeprafilmSeprafilm 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). | Device | Seprafilm Slurry |
| Sterile Saline SolutionFor those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline. | Device | Placebo |
Primary outcome
Presence of Iatrogenic Intrauterine Adhesions
Time frame: 2- 3 months after surgery
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
1 secondary outcome
Pregnancy Within 12 Months of Treatment
Time frame: Up to 12 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intrauterine Adhesions
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Recruiting
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Intrauterine Adhesion
Recruiting
To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial
Intrauterine Adhesion, Intrauterine Adhesions
Not yet recruiting
Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderate to Severe Intrauterine Adhesions
Intrauterine Adhesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogerio A Lobo, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seprafilm and Sterile Saline Solution in people with Intrauterine Adhesions, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Iatrogenic Intrauterine Adhesions (time frame: 2- 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.