NCT03446755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

2.9 years

First QC Date

January 24, 2018

Last Update Submit

July 1, 2021

Conditions

Adhesion; Uterus, Internal

Keywords

antiadhesion treatmentAsherman's syndromehysteroscopic adhesiolysisintrauterine adhesionsintrauterine balloon

Outcome Measures

Primary Outcomes (2)

  • The number of recurrent adhesions after adhesiolysis

    5-10 weeks after adhesiolysis

  • The number of complications after adhesiolysis

    5-10 weeks after adhesiolysis

Secondary Outcomes (8)

  • Pain after placement of the intra uterine balloon

    1 to 6 days after adhesiolysis

  • Complications after placement of the intra uterine balloon

    1 to 6 days after adhesiolysis

  • Pain at the time of the removal of the intra uterine balloon

    6 days after adhesiolysis

  • Patient Satisfaction after removal of the intra uterine balloon

    6 days after adhesiolysis

  • Malaise after placement of the intra uterine balloon

    6 days after adhesiolysis

  • +3 more secondary outcomes

Study Arms (1)

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.

Device: intra uterine Cook balloon

Interventions

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.

Intrauterine balloon (Cook medical)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female patients will be included
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with intra uterine adhesions scheduled for hysteroscopic adhesiolysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 36541390DERIVED

MeSH Terms

Conditions

Tissue AdhesionsGynatresia

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 27, 2018

Study Start

January 17, 2018

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)