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Completed

NCT Number: NCT04085198

Light Physics Enhanced Camera Navigation in Hysteroscopy

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.

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Key information

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Light physics enhanced 'no-touch' hysteroscopy

Procedure

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

Procedure

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 outcomes

  1. Procedural Pain

    Time frame: immediately after the procedure

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

  2. Procedure time

    Time frame: procedure

    The time required to perform the hysteroscopy

Secondary outcomes

  1. Patient satisfaction

    Time frame: immediately after the procedure

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

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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