Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier
ID
Source
Brief title
Condition
- Therapeutic and nontherapeutic effects (excl toxicity)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy endpoint:
AFS score focused on the intrauterine adhesion formation following Novasure
(i.e. considering only extent of cavity involved and type of adhesions after)
at 4-6 weeks
Primary safety endpoints:
1. Assessment of cavity findings at 4-6 weeks
a. Ability to perform a biopsy anywhere within the uterine cavity
b. Ability to adequately visualise the endometrium to evaluate for pathologic
change
c. Qualitative description of the endometrial cavity (i.e. presence of viable
endometrium vs cicatricial/fibrotic tissue*)
2. Number of Serious Adverse Events and Serious Device-related Adverse Events
at 3 months
Secondary outcome
1. Each component of AFS score at second look hysteroscopy: extent of IUA, type
of IUA
2. Binary rate of intrauterine adhesions on hysteroscopy
3. Change in menstrual bleeding at 3 months using Pictorial Blood Loss
Assessment Chart
4. Level of dysmenorrhea before and after 3 months (painful cramping associated
with menstruation)
5. Level of patient satisfaction on ablation procedure on a scale from 0 to 5
from the worst to the best health care possible.
6. Patients complaints (discharge, dyspareunia)
7. Is it possible to perform a second ablation procedure in case needed?
8. Histopathology assessment of hysterectomy piece (in the case a
hysterectomy is performed few years after endometrial ablation)
9. Histopathology assessment of endometrial biopsy taken at second look
hysteroscopy
Background summary
The application of endometrial ablation (EA) has significantly increased in the
past 10 years. It is an effective treatment for heavy menstrual bleeding with
functional aetiology, in the absence of other uterine pathology and child wish.
However, the risk of post-ablative intracavitary scarring after EA is
significant and can lead to long term complications, and the possible delay in
diagnosing of endometrial cancer , .
Although poorly documented, ablation using radiofrequency such as endometrial
ablation with Novasure has been associated with a high rate of post- ablation
intrauterine adhesions, limiting the ability to adequately evaluate the
endometrium by biopsy or hysteroscopy to address subsequent abnormal uterine
bleeding (AUB) .
In this clinical trial, we aim to perform a short term evaluation of the
uterine cavity and document the formation of adhesions with or without a
prevention barrier. Womed Leaf* is an intrauterine adhesion barrier film
specifically developed to prevent the formation or recurrence of intrauterine
adhesions after transcervical procedures, and it will be selected as the test
barrier in this study.
Results from this study, representing a relatively small cohort of patients,
will allow setting the hypothesis for a larger trial on long term EA outcomes
and complications depending on early management of adhesions.
Study objective
Evaluate the formation of adhesions after third-generation endometrial
ablation, with and without the intrauterine adhesion barrier
Study design
Prospective, multicenter, randomised, controlled, two-arm pilot clinical trial.
Intervention
Womed Leaf is inserted immediately after completion of the endometrial ablation
Name: Womed Leaf*
Device group: Intrauterine adhesion barrier
Device status: CE mark
Description:
Womed Leaf* is a sterile, degradable film of poly(D,L-lactide) (PLA) and
poly(ethylene oxide) (PEO). PEO is a biocompatible polymer with anti-adhesion
and swelling properties. It is polymerized with hydrophobic PLA to form a
degradable film
Womed Leaf* is inserted in the uterine cavity by a gynaecologist surgeon with a
5 mm diameter flexible inserter. Once released, the film unfolds and grows into
the uterine cavity to create a mechanical barrier and keep the uterine walls
separated for approximately one week. It is then degraded and discharged
naturally through the cervix.
Study burden and risks
No device-related adverse events were reported in the safety clinical study
PREG1 (NCT04381728), demonstrating that the device insertion is safe and the
uterine film is well tolerated by the patients.
Any known risks for participation in this study will be minimised through
centre selection and training as well as in the conduct and management of the
study, including a careful selection of patients, compliance with the protocol
and investigational device instructions for use.
The risk of performing additional second look hysteroscopy at 4-6 weeks
(study-specific) is comparable to an outpatient-based hysteroscopic diagnostic
procedure*s risks and complications. It will be done without anesthesia, which
is standard practice in the Netherlands.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
1.Patient with refractory heavy menstrual bleeding scheduled for endometrial
ablation with NovaSure system
2.Women 30 years old or older;
3.Subjects who are willing to provide a written informed consent as approved by
the applicable Ethics Committee / IRB prior to participating in this clinical
investigation.
4.Subjects who can comply with the study follow-up and other study
requirements.
Exclusion criteria
1. Cavity length <4 or >8
2. Perforation during the ablation procedure
3. Previous adhesiolysis procedure or diagnosis of Asherman's disease.
4. An abnormal uterine cavity at the time of ablation according to ESHRE
classification I to V, such as unicornis, bicornis, septate, duplex
5. Medical history of cervical or endometrial cancer
6. Active pelvic infection or medical history of pelvic peritonitis
7. An intrauterine device in situ
8. Known contraindication or hypersensitivity to PEO or PLA
9. Current participation in another clinical investigation that has not yet
received the primary endpoint
10. Any other condition that makes participation in the study contrary to the
patient*s best interests.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05414760 |
| CCMO | NL81229.100.22 |