NCT01637974

Brief Summary

The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

3.2 years

First QC Date

July 9, 2012

Last Update Submit

July 30, 2015

Conditions

Asherman SyndromeEndometrial PolypUterine Myoma

Outcome Measures

Primary Outcomes (1)

  • Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy

    one year

Study Arms (2)

with INTERCOAT

EXPERIMENTAL

injection of intercoat into the euterine cavity at the end of hysteroscopy

Drug: INTERCOAT administration

without INTERCOAT

NO INTERVENTION

without INTERCOAT

Interventions

INTERCOAT administrationDRUG

Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery

Also known as: INTERCOAT
with INTERCOAT

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 50 years
  • Must be able to understand, read and sign consent form

You may not qualify if:

  • Signs of infection upon admission
  • Ongoing pregnancy
  • Carcinoma of the uterus or cervix
  • Recurrent PID
  • Women admitted for endometrial ablation
  • Women that gave birth 6 weeks ago
  • Women participating in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Haifa District, Israel

RECRUITING

MeSH Terms

Conditions

GynatresiaMyofibroma

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Moran PAZ, M.D.

CONTACT

972-4-8250637MORANPA@CLALIT.GOV.IL

Yuval Kaufman, M.D.

CONTACT

972-4-8250345mdykaufman@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

December 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

IL(1)