NCT00755651

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

4.3 years

First QC Date

September 18, 2008

Last Update Submit

September 18, 2008

Conditions

Abnormal Uterine Bleeding

Keywords

MenorrhagiaUterine fibroidsEndometrial polypsEndometrial cancer

Outcome Measures

Primary Outcomes (1)

  • Discomfort

    End of procedure

Secondary Outcomes (1)

  • Procedure time, biopsy adequacy

    End of procedure

Study Arms (2)

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

Endometrial biopsyPROCEDURE

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Also known as: Pipelle, H Pipelle
H PipellePipelle

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Failed outpatient/office hysteroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 15958000RESULT

MeSH Terms

Conditions

MetrorrhagiaMenorrhagiaLeiomyomaEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Adam Magos, BSc MD FRCOG

    Royal Free Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

January 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

GB(1)