PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

NCT04381728 | Completed Results DMC

• 1 other identifier: PREG1
• Study Type: interventional
• Target: 23
• Locations: 3 countries
• Sites: 6

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.

Conditions

Intrauterine Adhesion

Keywords

myomectomy; Intrauterine adhesion; hysteroscopy

Outcome Measures

Primary Outcomes (4)

• Safety (Adverse Events)

  The number and severity of polymer film related adverse event

  30 days

• Efficacy (Rate of Patient With no IUA)

  Freedom from intrauterine adhesion

  At second look hysteroscopy between 4 and 8 weeks

• Efficacy (Intrauterine Adhesion Severity According to AFS Classification)

  Severity of IUAs according to American Fertility Society (AFS) classification systems of adhesions. Pronostic classification =\> Hysteroscopy score Stade I (mild) =\> 1-4 Stade II (moderate) =\> 5-8 Stade III (severe) =\> 9-12

  At second look hysteroscopy between 4 and 8 weeks

• Efficacy (Intrauterine Adhesion Severity According to ESGE Classification)

  Severity of IUAs according to European Society of Gynecological Endoscopy (ESGE) classification systems of adhesions. I =\> Thin or filmy IUA easily ruptured by HSC sheath alone. Cornual areas normal II =\> Singular dense IUA connecting separate parts of the uterine cavity. Visualization of both tubal ostia possible. Cannot be ruptured by HSC sheath alone IIa =\> Occluding IUA only in the region of the internal cervical os. Upper uterine cavity normal III =\> Multiple dense IUA connecting separate parts of the uterine cavity. Unilateral obliteration of ostial areas of the tubes IV =\> Extensive dense IUA with (partial) occlusion of the uterine cavity. Both tubal ostial areas (partially) occluded Va =\> Extensive endometrial scarring and fibrosis in combination with grade I or grade II IUA with amenorrhea or pronounced hypomenorrhea Vb =\> Extensive endometrial scarring and fibrosis in combination with grade III or grade IV IUA with amenorrhea

  At second look hysteroscopy between 4 and 8 weeks

Secondary Outcomes (6)

• Adverse Events

  30 days

• Device Technical Success

  During operation: T=0

• Womed Leaf Residuals

  At second look hysteroscopy: 4-8 weeks

• Womed Leaf Discharge Feedback : Time Interval in Days Between Surgery and Discharge

  At second look hysteroscopy: 4-8 weeks

• Device Manipulation

  During intervention: T=0

Study Arms (1)

Womed Leaf

EXPERIMENTAL

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

Interventions

Womed Leaf DEVICE

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

Womed Leaf

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Womed: lead

Study Sites (6)

UZ Gent

Ghent, Belgium

Location

CHU Nîmes

Nîmes, France

Location

CHU Bicêtre (APHP)

Paris, France

Location

Bergman Clinics

Amsterdam, Netherlands

Location

Zaans Medical Center

Amsterdam, Netherlands

Location

Isala Zwolle

Zwolle, Netherlands

Location

Related Publications (1)

• Weyers S, Capmas P, Huberlant S, Dijkstra JR, Hooker AB, Hamerlynck T, Debras E, De Tayrac R, Thurkow AL, Fernandez H. Safety and Efficacy of a Novel Barrier Film to Prevent Intrauterine Adhesion Formation after Hysteroscopic Myomectomy: The PREG1 Clinical Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):151-157. doi: 10.1016/j.jmig.2021.07.017. Epub 2021 Jul 31.

  PMID: 34343712 DERIVED

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: Pauline Chirouze
• Organization: WOMED

pauline@womedtech.com

0785225561

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 11, 2020
• Study Start: November 18, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (2); NL (3)