NCT01969396

Brief Summary

To assess the adequacy of an endometrial biopsy sample obtained using sonohysterography.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

October 17, 2013

Last Update Submit

December 22, 2014

Conditions

MenorrhagiaEndometrial NeoplasmsPolycystic Ovary SyndromeUterine Neoplasms

Keywords

BiopsyEndometrial biopsyEndometrial samplingsonohysterography

Outcome Measures

Primary Outcomes (2)

  • percentage of adequate endometrial biopsies utilizing sonohysterography

    7 days

  • percentage of adequate endometrial biopsies collected without sonohysterography

    7 days

Study Arms (2)

SonoBiopsy Catheter

EXPERIMENTAL
Device: SonoBiopsy Catheter

Endometrial biopsy catheter

ACTIVE COMPARATOR
Device: Endometrial biopsy catheter

Interventions

SonoBiopsy CatheterDEVICE

Catheter utilized in dual role: sonohysterography and endometrial biopsy

Also known as: Endometrial biopsy with sonohysterography
SonoBiopsy Catheter
Endometrial biopsy catheterDEVICE

Endometrial sample obtained without the assistance of sonohysterography

Also known as: Endometrial biopsy
Endometrial biopsy catheter

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with thickened endometrium
  • Abnormal uterine bleeding

You may not qualify if:

  • Pregnant
  • Active pelvic infection
  • Pelvic inflammatory disease
  • Blood clotting disorders
  • Sexually transmitted disease
  • Uterine perforation
  • Recent cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Punta Pacifica

Panama City, 8C6Q1 JGW8N, Panama

Location

MeSH Terms

Conditions

MenorrhagiaEndometrial NeoplasmsPolycystic Ovary SyndromeUterine Neoplasms

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsOvarian CystsCystsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ricardo Mastellari, MD

    Hospital Punta Pacifica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 25, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

PA(1)