Studies on the H Pipelle, a New Device for Endometrial Sa... | NCT00755651

Studies
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

NCT00755651

Sponsor

Royal Free Hampstead NHS Trust

Status

Completed

Last Update Posted

Sep 19, 2008Estimated

Enrollment

180Actual

Phase

Not Applicable

Conditions

Abnormal Uterine Bleeding

Interventions

Endometrial biopsy

Countries

United Kingdom

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

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Sep 18, 2008

First Submission Date that Met QC Criteria

Sep 18, 2008

First Posted Date

Sep 19, 2008Estimated

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

Sep 18, 2008

Last Update Posted Date

Sep 19, 2008Estimated

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 investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

Detailed Description

We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

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

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
H Pipelle	Experimental	Endometrial sample obtained using the H Pipelle	Procedure: Endometrial biopsy
Pipelle	Active Comparator	Endometrial sample obtained with standard Pipelle	Procedure: Endometrial biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endometrial biopsy	Procedure	Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy	H Pipelle Pipelle

Measure	Description	Time Frame
Discomfort		End of procedure

Measure	Description	Time Frame
Procedure time, biopsy adequacy		End of procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication to carry out diagnostic hysteroscopy
Agrees and is suitable for outpatient/office hysteroscopy

Exclusion Criteria:

Failed outpatient/office hysteroscopy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Magos, BSc MD FRCOG	Royal Free Hospital NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Free Hospital		London		NW3 2QG	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15958000	Result	Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. Outpatient hysteroscopy: traditional versus the 'no-touch' technique. BJOG. 2005 Jul;112(7):963-7. doi: 10.1111/j.1471-0528.2005.00425.x.

ID	Term
D008796	Metrorrhagia
D008595	Menorrhagia
D007889	Leiomyoma
D016889	Endometrial Neoplasms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases