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

Primary Purpose

Adhesion; Uterus, Internal

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intra uterine Cook balloon
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Adhesion; Uterus, Internal focused on measuring antiadhesion treatment, Asherman's syndrome, hysteroscopic adhesiolysis, intrauterine adhesions, intrauterine balloon

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Sites / Locations

  • University hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrauterine balloon (Cook medical)

Arm Description

Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.

Outcomes

Primary Outcome Measures

The number of recurrent adhesions after adhesiolysis
The number of complications after adhesiolysis

Secondary Outcome Measures

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).
Complications after placement of the intra uterine balloon
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).
Patient Satisfaction after removal of the intra uterine balloon
Via questionnaire
Malaise after placement of the intra uterine balloon
Via questionnaire
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).
The ease of inserting the intra uterine balloon
Via questionnaire
The ease of removing the intra uterine balloon
Via questionnaire

Full Information

First Posted
January 24, 2018
Last Updated
July 1, 2021
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03446755
Brief Title
Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions (REpAIR)
Official Title
The Use of an Intrauterine Balloon in Preventing Adhesion Recurrence After Hysteroscopic Adhesiolysis: a Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
December 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesion; Uterus, Internal
Keywords
antiadhesion treatment, Asherman's syndrome, hysteroscopic adhesiolysis, intrauterine adhesions, intrauterine balloon

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrauterine balloon (Cook medical)
Arm Type
Experimental
Arm Description
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
Intervention Type
Device
Intervention Name(s)
intra uterine Cook balloon
Intervention Description
Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
Primary Outcome Measure Information:
Title
The number of recurrent adhesions after adhesiolysis
Time Frame
5-10 weeks after adhesiolysis
Title
The number of complications after adhesiolysis
Time Frame
5-10 weeks after adhesiolysis
Secondary Outcome Measure Information:
Title
Pain after placement of the intra uterine balloon
Description
via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).
Time Frame
1 to 6 days after adhesiolysis
Title
Complications after placement of the intra uterine balloon
Time Frame
1 to 6 days after adhesiolysis
Title
Pain at the time of the removal of the intra uterine balloon
Description
via Visual Analogue Scale (VAS scale). The patient has to indicate her pain score from 0 (no pain) to 10 (worst pain ever).
Time Frame
6 days after adhesiolysis
Title
Patient Satisfaction after removal of the intra uterine balloon
Description
Via questionnaire
Time Frame
6 days after adhesiolysis
Title
Malaise after placement of the intra uterine balloon
Description
Via questionnaire
Time Frame
6 days after adhesiolysis
Title
Daily functioning after placement of the intra uterine balloon (absence from work, impact on work productivity, impact on household, physical activity, daily life)
Description
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).
Time Frame
6 days after adhesiolysis
Title
The ease of inserting the intra uterine balloon
Description
Via questionnaire
Time Frame
once at the time of the surgical procedure (adhesiolysis). This is day 0 of the study
Title
The ease of removing the intra uterine balloon
Description
Via questionnaire
Time Frame
6 days after adhesiolysis

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female patients will be included
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis
Facility Information:
Facility Name
University hospital Ghent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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