Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing In... | NCT01637974

Studies
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery

NCT01637974

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Jul 31, 2015Estimated

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Asherman Syndrome
Endometrial Polyp
Uterine Myoma

Interventions

INTERCOAT administration

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jul 9, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
INTERCOAT administration	Drug	Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery	with INTERCOAT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Moran PAZ, M.D.	Contact	972-4-8250637		MORANPA@CLALIT.GOV.IL
Yuval Kaufman, M.D.	Contact	972-4-8250345		mdykaufman@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa	Haifa District		Israel

Condition Browse Module

MeSH Terms

ID	Term
D006175	Gynatresia
D047708	Myofibroma

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided