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PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film (PREG1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381728
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Womed

Brief Summary:

Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.

Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.


Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Device: Womed Leaf Not Applicable

Detailed Description:

Intrauterine adhesions (IUA) are defined as "fibrous strings at opposing walls of the uterus and/or cervix leading to partial or complete obliteration of the cavity". IUAs are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complications and infertility.

Womed Leaf™ is a sterile, degradable polymer film specifically design for intrauterine use. It is inserter in the uterus like an intrauterine device. Once released it will self-deploy into the uterine cavity to form a mechanical barrier keeping uterus walls separated during healing, for several days, thus preventing the formation or recurrence of intrauterine adhesions. It is degraded and discharged naturally through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is a prospective multicenter, single arm study, designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy in preventing IUA at second look hysteroscopy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Womed Leaf

At the end of the hysteroscopic myomectomy, Womed Leaf is delivered in the uterus thanks to a 5mm diameter, flexible inserter. Then an endovaginal ultrasound will be performed to assess the positioning of the uterine film.

Another ultrasound will be performed at 2 hours, prior to patient discharge in order to record images of the uterine film deployment.

A second look hysteroscopy will performed at 4-8 weeks to evaluate the presence of intrauterine adhesion.

Device: Womed Leaf
Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.




Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: 30 days ]
    The number and severity of polymer film related adverse event

  2. Efficacy (intrauterine adhesion rate) [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]
    Freedom from intrauterine adhesion

  3. Efficacy (intrauterine adhesion severity according to AFS classification) [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]
    Severity of IUAs according to American Fertility Society (AFS) classification systems of adhesions.

  4. Efficacy (intrauterine adhesion severity according to ESGE classification) [ Time Frame: At second look hysteroscopy between 4 and 8 weeks ]
    Severity of IUAs according to European Society of Gynecological Endoscopy (ESGE) classification systems of adhesions.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 30 days ]
    Number, type and severity of adverse events (AE) at 30 days

  2. Performance [ Time Frame: During operation: T=0 ]
    Performance: device technical success, defined as success of the following 2 steps : insertion and release

  3. Menstrual bleeding [ Time Frame: At second look hysteroscopy: 4-8 weeks ]
    Menstrual bleeding according to Higham score (calculated from recorded number of tampons and sanitary pads used each days)

  4. Womed Leaf residuals [ Time Frame: At second look hysteroscopy: 4-8 weeks ]
    Presence of Womed Leaf residuals in the uterus

  5. Womed Leaf discharge feedback questionnaire [ Time Frame: At second look hysteroscopy: 4-8 weeks ]
    Uterine film discharge experience as recalled by subject using a survey to be asked to the patient

  6. Device manipulation [ Time Frame: During intervention: T=0 ]
    Device manipulation duration from insertion to withdrawal.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ≥ 40 years AND no childbearing wish, OR history of permanent sterilization;
  • Subject scheduled for hysteroscopic myomectomy for one or more myoma(s) where one myoma is at least 10 mm in size (≥10mm) as estimated by pre-operative ultrasound measurement of the largest diameter,
  • Hysterometry prior to device insertion ≥ 6cm and ≤ 9cm.
  • Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee prior to participating in this clinical investigation.
  • Subjects who can comply with the study follow-up or other study requirements

Exclusion Criteria:

Pre-operative exclusion criteria:

  • Current pregnancy
  • Abnormal uterine cavity according to ESHRE classification I to VI, such as unicornis, bicornis, septate, duplex
  • Known or suspected endometrial hyperplasia
  • Medical history of cervical or endometrial cancer
  • Active pelvic infection or medical history of pelvic peritonitis
  • Intrauterine device in situ
  • Known contraindication or hypersensitivity to PEO or PLA, and to medications such as aspirin….
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Full endometrial ablation

Per-operative exclusion criteria:

  • Adenomyosis
  • Inflammation (endometritis)
  • Abnormal uterine cavity
  • Hysterometry < 6cm or >9cm
  • Any complication during the intervention that is deemed to potentially interfere with the objective of the study by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381728


Contacts
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Contact: Pauline CHIROUZE 0785225561 pauline@womedtech.com

Locations
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Belgium
UZ Gent Recruiting
Gent, Belgium
Contact: Steven Weyers         
CHR La Citadelle Not yet recruiting
Liège, Belgium
Contact: Michelle Nisolle         
France
CHU Nîmes Not yet recruiting
Nîmes, France
Contact: Renaud De Tayrac         
CHU Bicêtre (APHP) Not yet recruiting
Paris, France
Contact: Hervé Fernandez         
Netherlands
Bergman Clinics Recruiting
Amsterdam, Netherlands
Contact: Andreas Thurkow         
Zaans Medical Center Not yet recruiting
Amsterdam, Netherlands
Contact: Angelo Hooker         
Isala Zwolle Recruiting
Zwolle, Netherlands
Contact: Jeroen Dijkstra         
Sponsors and Collaborators
Womed
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Responsible Party: Womed
ClinicalTrials.gov Identifier: NCT04381728    
Other Study ID Numbers: PREG1
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing of individual participant data is planed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Womed:
myomectomy
Intrauterine adhesion
hysteroscopy
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes