Light Physics Enhanced Camera Navigation in Hysteroscopy

Infertility Clinical Trial

Official title:

Light Physics Enhanced Camera Navigation in No-touch Hysteroscopy: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085198
• Other study ID #: Huseyin5
• Status: Completed
• Phase: N/A
• Start date: September 13, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: February 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 25, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Light physics enhanced 'no-touch' hysteroscopy
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.
• Standard hysteroscopy
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

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Please Enter The State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Pain	The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)	immediately after the procedure
Primary	Procedure time	The time required to perform the hysteroscopy	procedure
Secondary	Patient satisfaction	Patients' self-reported satisfaction (satisfied or not satisfied with the procedure)	immediately after the procedure