Prevention of Adhesions During Celioscopy for Endometrios... | NCT02612818

Studies
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year

NCT02612818

Sponsor

Nordic Pharma SAS

Status

Unknown status

Last Update Posted

Aug 1, 2018Actual

Enrollment

364Actual

Phase

Not provided

Conditions

Endometriosis, Adhesive

Interventions

Coelioscopy

Countries

France

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2015Actual

Primary Completion Date

Jul 2018Actual

Completion Date

May 2019Estimated

First Submitted Date

Nov 20, 2015

First Submission Date that Met QC Criteria

Nov 23, 2015

First Posted Date

Nov 24, 2015Estimated

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 31, 2018

Last Update Posted Date

Aug 1, 2018Actual

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

Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.

The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

364Actual

Name	Type	Description	Arm Group Labels	Other Names
Coelioscopy	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change on the clinical signs	The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.).	At 2 months and one year after the baseline visit (i.e. celioscopy)
Fertility	rate of pregnancy women	One year after the baseline visit (i.e. celioscopy)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
Patients accepting and able to update a questionnaire in French.
Informed patients who agree to computerised processing of their medical data and their right of access and rectification.

Exclusion Criteria:

Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
Patients not wishing to become pregnant.
Patients participating or having participated during the previous month in a gynaecological clinical trial.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subsequent patients of procreation age having undergone a cœlioscopy for endometriosis, for whom a spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately, and meeting all of the selection criteria will be included in the study.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Hélène HERMAN-DEMARS, MD	Nordic Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nordic Pharma		Paris		75007	France

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

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

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided