search
Back to results

Light Physics Enhanced Camera Navigation in Hysteroscopy

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Light physics enhanced 'no-touch' hysteroscopy
Standard hysteroscopy
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Multiparous women
  • Previous cesarean section
  • Cervical stenosis

Sites / Locations

  • Kanuni Sultan Suleyman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

No-touch technique with the application of light physics rules

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Procedural Pain
The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)
Procedure time
The time required to perform the hysteroscopy

Secondary Outcome Measures

Patient satisfaction
Patients' self-reported satisfaction (satisfied or not satisfied with the procedure)

Full Information

First Posted
September 9, 2019
Last Updated
February 19, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04085198
Brief Title
Light Physics Enhanced Camera Navigation in Hysteroscopy
Official Title
Light Physics Enhanced Camera Navigation in No-touch Hysteroscopy: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 13, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Office hysteroscopy is basically used in the diagnosis of the intrauterine pathologies. 'No touch' vaginal hysteroscopy does not require a speculum or tenaculum; thus, confers advantages in terms of patient discomfort over the traditional technique. The source of the pain in traditional hysteroscopy is the distention of the uterine cavity with the saline and the contact of the hysteroscopy equipment with the vagina and the cervical canal. The benefit in the pain obtained with the 'no-touch' technique is derived from the limitation of the contact of the hysteroscopy equipment with the vagina and the cervical canal. 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. Physics has been critical in the development of endoscopic techniques such as laparoscopy, cystoscopy, and hysteroscopy. The light source 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. With this in mind, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No-touch technique with the application of light physics rules
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Light physics enhanced 'no-touch' hysteroscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard hysteroscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
Procedural Pain
Description
The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)
Time Frame
immediately after the procedure
Title
Procedure time
Description
The time required to perform the hysteroscopy
Time Frame
procedure
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patients' self-reported satisfaction (satisfied or not satisfied with the procedure)
Time Frame
immediately after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be scheduled for No-touch Office hysteroscopy procedure with a diagnostic purpose Must be nulliparous Exclusion Criteria: Multiparous women Previous cesarean section Cervical stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin Kiyak, MD
Organizational Affiliation
University of Health Sciences, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Please Enter The State Or Province
ZIP/Postal Code
34005
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Light Physics Enhanced Camera Navigation in Hysteroscopy

We'll reach out to this number within 24 hrs