NCT01464528

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Nov 2011

Shorter than P25 for early_phase_1

Status
unknown

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

First Submitted

Initial submission to the registry

August 15, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 3, 2011

Status Verified

July 1, 2011

Enrollment Period

4 months

First QC Date

August 15, 2011

Last Update Submit

November 2, 2011

Conditions

Tissue Adhesions

Keywords

hysteroscopypostoperative complicationsadhesionshyaluronic gelprevention

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction following gel application

    2 months

Study Arms (2)

Hyaluronan

ACTIVE COMPARATOR

Use of hyaluronic acid gel

Drug: Hyaluronan

control

NO INTERVENTION

Interventions

HyaluronanDRUG

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

Also known as: hyaluronic acid, alcohol and carboxil
Hyaluronan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tissue AdhesionsPostoperative Complications

Interventions

Hyaluronic AcidEthanol

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesAlcoholsOrganic Chemicals

Study Officials

  • Ariel Revel, MD

    Hadassah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ariel revel, md

CONTACT

97226777111arielr2@hadassah.org.il

hanna Bechori

CONTACT

97226777111hannab@hadassah.org.il

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2011

First Posted

November 3, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

November 3, 2011

Record last verified: 2011-07