PREvention of intrauterine adhesion after hysteroscopic surgery with novel deGradable film

IUAs are the major long-term complication of operative hysteroscopy. Their
prevalence following myomectomy is high (31.3%-45.5%, , and they are
frequently associated with pelvic pain . According to the Cochrane review
performed by Bosteels et al, the effectiveness of the anti-adhesion techniques
evaluated in the literature in decreasing intrauterine adhesions following
hysteroscopy in subfertile women remains uncertain . The latest study by Hooker
et al demonstrates that barrier gel can reduce IUAs formation. However IUAs
still develop and there is room for improvement in adhesion formation
prevention.
The prevention tools available today do not sufficiently meet the
specifications required for the prevention of IUAs which are: 1) ergonomic
device, specifically designed for intrauterine use and adapted to the cervical
passage and 2) anti-adhesion barrier that keep the wound tissue apart during
the repair phase for optimal efficiency. *Results can be used to prevent
adhesions and to preserve the ability to become pregnant

The objective of the present study is to evaluate the safety of Womed Leaf
after hysteroscopic myomectomy and its potential efficacy in preventing IUA at
second look hysteroscopy.

This is a prospective, multi-center, single arm clinical study. Second look
hysteroscopy at 4-8 months will enable to assess device efficacy.

Womed Leaf* is inserted in the uterine cavity by a gynecologist surgeon as a
film folded into a 5 mm diameter flexible inserter. Once released, the film
will unfold and swell into the uterine cavity to keep uterus walls separated
during approximately 5 days. It is degraded and discharged naturally through
the cervix and vagina in less than 30 days

There are three types of risk:
1. Risk associated with inserting the film through the applicator. However,
this type of risk is small because the device is specifically designed for
introduction into the uterus in a non-traumatic manner. These risks are:

* Damage to the cervix if it closes spontaneously after hysteroscopy, thus
causing some fricture when applying the film. These small lesions heal
spontaneously.
* Very rarely, uterine perforation may occur. There is then a risk that
surrounding organs will be damaged. A viewing operation through the abdominal
wall may then be necessary to assess the potential damage and remove the film
if it is in the abdominal cavity.

2.Tolerance for the film itself. The film is made up of various elements
(polylactic acid and polyethylene oxide). These elements are already being used
in a number of other clinical applications: suture, bone implants, cosmetics,
medicines. The tolerance of the film has been thoroughly studied and the
results show that the film does not cause a reaction when it comes into contact
with tissues.
However, it is possible that an allergic reaction or infection may occur that
leads to itching, discomfort or fever, pain or bleeding. This may then be due
to surgical hysteroscopy or to Womed Leaf. If the film was not tolerated by the
uterus, it is possible that the film will be rejected by uterine contraction.
Animal studies have shown that the film will be degraded and excreted within 28
days, ro be confirmed by the hysteroscopy at 4-8 weeks. If part of the film is
still present, this should have no consequences due to the excellent tolerance
of the substance.

3.Risks associated with operative hysteroscopy itself. These risks are
therefore related to the surgical procedure and not to Womed Leaf.

The burden on the patient is low, only insertion through an applicator after
the operative hysteroscopy. further only follow-up after 30 days and a
follow-up viewing after 4-8 weeks. The risks are reduced as much as possible
through targeted site selection and training, and proctoring. The Instructions
for use have been developed as well as possible.
Any known risks for participation in this study have been minimized during the
development process of the device and will be minimized through center
selection and training, proctoring 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