NCT04085198

Brief Summary

Office hysteroscopy is the gold standard technique in the diagnosis of the intrauterine pathologies. Some interventions may also be carried out through the hysteroscopy. No-touch hysteroscopy technique confers several advantages in terms of patient discomfort over the traditional technique. Clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route. The investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. This study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

September 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

September 9, 2019

Last Update Submit

February 19, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • Procedural Pain

    The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)

    immediately after the procedure

  • Procedure time

    The time required to perform the hysteroscopy

    procedure

Secondary Outcomes (1)

  • Patient satisfaction

    immediately after the procedure

Study Arms (2)

No-touch technique with the application of light physics rules

ACTIVE COMPARATOR

This procedure will be performed by the gynecologists who are familiar to the rules of the 'lights physics' and are currently 'lights physics' rules in their clinical practice. The brightness or darkness of the tissue which reflects the distance between the light source and the surrounding tissue will be used to find the correct route from the vagina introitus to the uterine cavity.

Procedure: Light physics enhanced 'no-touch' hysteroscopy

Control

PLACEBO COMPARATOR

Patients in this arm of the study protocol will receive standard hysteroscopy with 'no-touch' technique without the utilization of the 'lights physics' rules. The gynecologist performing this procedure will find their route from the vagina introitus to the uterine cavity by the identification of the anatomical structures on their way.

Procedure: Standard hysteroscopy

Interventions

Light physics enhanced 'no-touch' hysteroscopyPROCEDURE

The light source used in hysteroscopy provides an illumined environment during the imagination with these techniques. During hysteroscopy, the light reflecting from the adjacent tissue appears bright, however, this reflection is weaker in farther tissue and these structures appear dark. This information will be used in determining the route from the vaginal introitus to the uterine cavity during the hysteroscopy.

No-touch technique with the application of light physics rules
Standard hysteroscopyPROCEDURE

Anatomical structures as illumined by the light source of the camera will be used to find the route from the vaginal introitus to the uterine cavity

Control

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be scheduled for No-touch Office hysteroscopy procedure with a diagnostic purpose
  • Must be nulliparous

You may not qualify if:

  • Multiparous women
  • Previous cesarean section
  • Cervical stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Huseyin Kiyak, MD

    University of Health Sciences, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D.

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

September 13, 2019

Primary Completion

November 20, 2019

Study Completion

November 25, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)