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Safety Study of Use of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01464528
Enrollment
10
Registered
2011-11-03
Start date
2011-11-30
Completion date
2012-05-31
Last updated
2011-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Adhesions

Keywords

hysteroscopy, postoperative complications, adhesions, hyaluronic gel, prevention

Brief summary

Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.

Detailed description

Operations in the uterus are currently possible using a hysteroscopic approach. Intrauterine procedures include; polypectomy, myomectomy, removal of lost IUD,removal of a septum and more. One serious though rare complication of operative hysteroscopy is the development of intra-uterine adhesions. Such adhesions, also known as asherman's syndrome, can cause serious consequences such as infertility and miscarriage. The hypothesis is that the removal of the endometrium and the exposure of ra uterine wall to each other can cause attachment and adhesions. the treatment is to mechanically break the adhesion. recurrence is however common. There currently are no methods to prevent adhesions following curettage or hysteroscopy. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery. At a later research, the efficacy of barrier gel will be measures.

Interventions

single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age 18 year old and over * need of hysteroscopic surgery

Exclusion criteria

* preoperative fever or infection * malignancy * previous PID * contraindications for anesthesia * pregnancy * under 18 year old * not able to read and/or understand informed consent * taking any medicine other than oral contraceptives

Design outcomes

Primary

MeasureTime frame
Patient satisfaction following gel application2 months

Contacts

Primary Contactariel revel, md
arielr2@hadassah.org.il97226777111
Backup Contacthanna Bechori
hannab@hadassah.org.il97226777111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026