NCT02101827

Brief Summary

To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

March 6, 2014

Last Update Submit

July 4, 2015

Conditions

Hysteroscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Safety of manual fluid-distension methods for hysteroscopic procedures

    The complications (such as hyponatremia, abdominal pain) related to manual fluid-distension methods for hysteroscopic procedures.

    1 week

Secondary Outcomes (1)

  • Feasibility of manual fluid-infusion methods for hysteroscopic procedures

    1 week

Study Arms (1)

Hysteroscopic surgery

Women who received hysteroscopic surgeries or examinations

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose

You may qualify if:

  • Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
  • Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose from June 2010 to November 2013 in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.

You may not qualify if:

  • Female patients of less than twenty years-old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

March 6, 2014

First Posted

April 2, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

TW(1)