Adhesion; Uterus, InternalNCT03446755
Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)
A study testing intra uterine Cook balloon in people with Adhesion; Uterus, Internal, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Adhesion; Uterus, Internal
- What is being tested?
- intra uterine Cook balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jan 2018to 16 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.
Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation.
A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.
We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to study its feasibility in terms of surgeon's and patient's experience.
- Conditions
- Adhesion; Uterus, Internal
- Being tested
- intra uterine Cook balloon
- Keywords
- antiadhesion treatment, Asherman's syndrome, hysteroscopic adhesiolysis, intrauterine adhesions, intrauterine balloon
- Medical subject headings
- Tissue Adhesions, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra uterine Cook balloonDevice
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine balloon (Cook medical) | Experimental | Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. Receives: Device: intra uterine Cook balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of recurrent adhesions after adhesiolysis
Measured: 5-10 weeks after adhesiolysis
The number of complications after adhesiolysis
Measured: 5-10 weeks after adhesiolysis
Secondary outcomes (8)
Pain after placement of the intra uterine balloon
via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).
Measured: 1 to 6 days after adhesiolysis
Complications after placement of the intra uterine balloon
Measured: 1 to 6 days after adhesiolysis
Pain at the time of the removal of the intra uterine balloon
via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).
Measured: 6 days after adhesiolysis
Patient Satisfaction after removal of the intra uterine balloon
Via questionnaire
Measured: 6 days after adhesiolysis
Malaise after placement of the intra uterine balloon
Via questionnaire
Measured: 6 days after adhesiolysis
Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)
Via questionnaire and via via Visual Analogue Scale (VAS scale). The patient has to indicate her daily functioning from 0 (the balloon had no influence on my daily function) to 10 (because of the balloon I couldn't do anything of my daily work).
Measured: 6 days after adhesiolysis
The ease of inserting the intra uterine balloon
Via questionnaire
Measured: once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study
The ease of removing the intra uterine balloon
Via questionnaire
Measured: 6 days after adhesiolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start17 Jan 2018
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesion; Uterus, InternalStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the feasibility of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis in terms of surgeon's and patient's experience.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446755
- Sponsor's protocol ID
- B670201733915
- Status last verified
- Jun 2021
- First submitted
- 24 Jan 2018
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Wessel S, Wauters L, Weyers S, Hamerlynck T. The use of an intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis: a feasibility study. J Obstet Gynaecol. 2022 Nov;42(8):3720-3724. doi: 10.1080/01443615.2022.2158320. Epub 2022 Dec 21.
PubMed 36541390
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT03446755
- Acronym / sponsor ID
- B670201733915
- Conditions
- Adhesion; Uterus, Internal
- Keywords
- antiadhesion treatment, Asherman's syndrome, hysteroscopic adhesiolysis, intrauterine adhesions, intrauterine balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 27 Feb 2018 (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.
Patients suffering of subfertility as a consequence of intrauterine adhesions could be treated with hysteroscopic adhesiolysis. Adhesion recurrence may occur postoperative. An intrauterine balloon, inserted after hysteroscopic adhesiolysis, may prevent adhesion reformation.
A Foley catheter can serve for this purpose, but its not ideal. COOK medical® developed a hearth shaped intrauterine balloon to reduce bleeding after intrauterine surgery.
We aimed to perform a pilot study of 10 procedures with insertion of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis, to study its feasibility in terms of surgeon's and patient's experience.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the feasibility of a hearth shaped intrauterine balloon as antiadhesion method subsequent to a hysteroscopic adhesiolysis in terms of surgeon's and patient's experience.
| Arm | Type | Receives |
|---|---|---|
| Intrauterine balloon (Cook medical) | Experimental | Device: intra uterine Cook balloonInsertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| intra uterine Cook balloonInsertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis. | Device | Intrauterine balloon (Cook medical) |
Primary outcome
The number of recurrent adhesions after adhesiolysis
Time frame: 5-10 weeks after adhesiolysis
The number of complications after adhesiolysis
Time frame: 5-10 weeks after adhesiolysis
8 secondary outcomes
Pain after placement of the intra uterine balloon
Time frame: 1 to 6 days after adhesiolysis
Complications after placement of the intra uterine balloon
Time frame: 1 to 6 days after adhesiolysis
Pain at the time of the removal of the intra uterine balloon
Time frame: 6 days after adhesiolysis
Patient Satisfaction after removal of the intra uterine balloon
Time frame: 6 days after adhesiolysis
Malaise after placement of the intra uterine balloon
Time frame: 6 days after adhesiolysis
Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)
Time frame: 6 days after adhesiolysis
The ease of inserting the intra uterine balloon
Time frame: once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study
The ease of removing the intra uterine balloon
Time frame: 6 days after adhesiolysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 36541390van Wessel S, Wauters L, Weyers S, Hamerlynck T. The use of an intrauterine balloon in preventing adhesion recurrence after hysteroscopic adhesiolysis: a feasibility study. J Obstet Gynaecol. 2022 Nov;42(8):3720-3724. doi: 10.1080/01443615.2022.2158320. Epub 2022 Dec 21.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra uterine Cook balloon in people with Adhesion; Uterus, Internal, 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 2 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of recurrent adhesions after adhesiolysis (time frame: 5-10 weeks after adhesiolysis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446755, which also lists 1 linked publication.
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 2 Jul 2021.