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Light Physics Enhanced Camera Navigation in Hysteroscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04085198
Enrollment
96
Registered
2019-09-11
Start date
2019-09-13
Completion date
2019-11-25
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

PROCEDURELight 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.

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

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Procedural Painimmediately after the procedureThe visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)
Procedure timeprocedureThe time required to perform the hysteroscopy

Secondary

MeasureTime frameDescription
Patient satisfactionimmediately after the procedurePatients' self-reported satisfaction (satisfied or not satisfied with the procedure)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026