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Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)

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ClinicalTrials.gov Identifier: NCT03446755
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Patients suffering of subfertility as a consequence of intra uterine adhesions could be treated with adhesiolysis by hysteroscopy. Post-operative recurrent adhesions could be developed. To prevent these recurrent adhesions, an intra uterine balloon is inserted as a barrier. The investigator wants to test if the intra uterine balloon is a good alternative for the current used intra uterine device or gel.

Condition or disease Intervention/treatment Phase
Adhesion; Uterus, Internal Device: intra uterine Cook balloon Not Applicable

Detailed Description:

Patients suffering of subfertility as a consequence of intra uterine adhesions could be treated with adhesiolysis by hysteroscopy. Post-operative recurrent adhesions could be developped. To prevent these recurrent adhesions, an intra uterine balloon is inserted as a barrier. The investigator wants to test if the intra uterine balloon is a good alternative for the current used intra uterine device or gel.

The investigator wants to include 20 patients with intra uterine adhesions and who need a adhesiolysis by hysteroscopy. The intra uterine balloon will be placed after the adhesiolysis and will be removed after 6 days. During these 6 days an antibiotic cure together with the standard hormone therapy will be administered to the patient. During the 6 days the patients will need to evaluate their pain, the comfort of the balloon, the impact on their daily functioning and their satisfaction.

After 6 days, the balloon will be removed and again a pain score together with a score for the ease of removing the balloon will be collected .

After 8 weeks a second look hysteroscopy will be planned to check the degree of adhesion and if there are any other complications.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The aim of this pilot study study is to test if the device is feasible in preventing adhesions to develop again after adhesiolsysis.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The Use of Intra Uterine Balloon to Prevent Recurrent Adhesions After Adhesiolysis by Hysteroscopy: Pilot Study
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Intra uterine Cook balloon Device: intra uterine Cook balloon
An intra uterine Cook balloon will be placed after adhesiolysis to prevent recurrent adhesions after adhesiolysis by hysteroscopy.




Primary Outcome Measures :
  1. The number of recurrent adhesions after adhesiolysis [ Time Frame: 8 weeks after adhesiolysis ]
  2. The number of complications after adhesiolysis [ Time Frame: 8 weeks after adhesiolysis ]

Secondary Outcome Measures :
  1. Pain after placement of the intra uterine balloon [ Time Frame: 1 to 6 days after adhesiolysis ]
    via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).

  2. Complications after placement of the intra uterine balloon [ Time Frame: 1 to 6 days after adhesiolysis ]
  3. Pain at the time of the removal of the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).

  4. Patient Satisfaction after removal of the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire

  5. Malaise after placement of the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire

  6. 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 ]
    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).

  7. 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 ]
    Via questionnaire

  8. The ease of removing the intra uterine balloon [ Time Frame: 6 days after adhesiolysis ]
    Via questionnaire



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female patients will be included
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with intra uterine adhesions or Asherman syndrome who need adhesiolysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446755


Contacts
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Contact: Steven Weyers, prof 003293323783 steven.weyers@uzgent.be
Contact: Eline Meireson, Msc 0032 9 332 78 17 eline.meireson@uzgent.be

Locations
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Belgium
University hospital Ghent Recruiting
Ghent, East-Flanders, Belgium, 9000
Contact: Eline Meireson, Msc    003293327817    eline.meireson@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03446755     History of Changes
Other Study ID Numbers: B670201733915
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes