MyomaPALLMNCT05683041
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
A study testing Hyalobarrier in people with Myoma, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy. Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myoma
- What is being tested?
- Hyalobarrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Feb 2023to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 45 years.
- intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
- absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
Who cannot join
- pregnancy.
- laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
- presence of endometritis.
- other antiadhesion methods
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent
Steffi van Wessel, Dr., 093320758
Steven Weyers, Prof. Dr., 093320758
About this study
Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.
Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.
Read the detailed description
Design:
Double-blind, randomized controlled pilot trial.
Participant:
- age between 18 and 45 years.
- intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
- absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
Treatment:
Application of intrauterine Hyalobarrier® gel endo at time of surgery
Control:
No application of Hyalobarrier® gel endo
Follow up:
Second-look hysteroscopy after 3months
To blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.
- Conditions
- Myoma
- Being tested
- Hyalobarrier
- Keywords
- Postoperative adhesions, Intrauterine adhesions, Myomectomy, Laparoscopic myomectomy, Laparotomic myomectomy, Adhesion prevention, Antiadhesion method
- Medical subject headings
- Myoma, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyalobarrierDevice
Also called anti-adhesive gel
Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.
| Study group | Role | What they receive |
|---|---|---|
| intrauterine gel application | Experimental | Application of Hyalobarrier intrauterine after myomectomy. Receives: Device: Hyalobarrier |
| no intra-uterine gel application | No intervention | No application of Halobarrier intrauterine after myomectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion formation postoperatief.
The presence of intra-uterine adhesions on a second look hysteroscopy.
Measured: 3 months post surgery
Secondary outcomes (1)
Severity of adhesion formation
American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity.
Measured: 3 months post surgery, at the time of the hysteroscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start22 Feb 2023
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions. The application of antiadhesion gel is compared to no gel.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Pharma SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683041
- Sponsor's protocol ID
- ONZ-2022-0355
- Acronym
- PALLM
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
- ClinicalTrials.gov ID
- NCT05683041
- Acronym / sponsor ID
- PALLM / ONZ-2022-0355
- Conditions
- Myoma
- Keywords
- Postoperative adhesions, Intrauterine adhesions, Myomectomy, Laparoscopic myomectomy, Laparotomic myomectomy, Adhesion prevention, Antiadhesion method
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Nordic Pharma SAS
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.
Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.
Detailed description
Design:
Double-blind, randomized controlled pilot trial.
Participant:
- age between 18 and 45 years.
- intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
- absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
Treatment:
Application of intrauterine Hyalobarrier® gel endo at time of surgery
Control:
No application of Hyalobarrier® gel endo
Follow up:
Second-look hysteroscopy after 3months
To blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions. The application of antiadhesion gel is compared to no gel.
| Arm | Type | Receives |
|---|---|---|
| intrauterine gel application | Experimental | Device: HyalobarrierApplication of Hyalobarrier intrauterine after myomectomy. |
| no intra-uterine gel application | No intervention | –No application of Halobarrier intrauterine after myomectomy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 45 years.
- intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
- absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
Key exclusion criteria (4 listed)
- pregnancy.
- laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
- presence of endometritis.
- other antiadhesion methods
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 |
|---|---|---|
| HyalobarrierAlso: anti-adhesive gelHyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity. | Device | intrauterine gel application |
Primary outcome
Adhesion formation postoperatief.
Time frame: 3 months post surgery
The presence of intra-uterine adhesions on a second look hysteroscopy.
1 secondary outcome
Severity of adhesion formation
Time frame: 3 months post surgery, at the time of the hysteroscopy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalobarrier in people with Myoma, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steffi Van Wessel, Dr. (093320758, studieco.vrouwenkliniek@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion formation postoperatief. (time frame: 3 months post 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 20 Aug 2026.