InfertilityNCT04085198
Light Physics Enhanced Camera Navigation in Hysteroscopy
A study testing Light physics enhanced 'no-touch' hysteroscopy and Standard hysteroscopy in people with Infertility, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Light physics enhanced 'no-touch' hysteroscopy and Standard hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2019to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must be scheduled for No-touch Office hysteroscopy procedure with a diagnostic purpose
- Must be nulliparous
Who cannot join
- Multiparous women
- Previous cesarean section
- Cervical stenosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Please Enter the State Or Province, 34005
About this study
Official title: Light Physics Enhanced Camera Navigation in No-touch Hysteroscopy: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Light physics enhanced 'no-touch' hysteroscopy, Standard hysteroscopy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light physics enhanced 'no-touch' hysteroscopyProcedure or surgery
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 hysteroscopyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain
The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)
Measured: immediately after the procedure
Procedure time
The time required to perform the hysteroscopy
Measured: procedure
Secondary outcomes (1)
Patient satisfaction
Patients' self-reported satisfaction (satisfied or not satisfied with the procedure)
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start13 Sep 2019
- Primary completion20 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Kiyak, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Huseyin Kiyak, MD, Principal investigator, University of Health Sciences, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085198
- Sponsor's protocol ID
- Huseyin5
- Status last verified
- Feb 2020
- First submitted
- 9 Sep 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Physics Enhanced Camera Navigation in No-touch Hysteroscopy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04085198
- Acronym / sponsor ID
- Huseyin5
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-touch technique with the application of light physics rules | Active comparator | Procedure: Light physics enhanced 'no-touch' hysteroscopyThis 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. |
| Control | Placebo comparator | Procedure: Standard hysteroscopyPatients 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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be scheduled for No-touch Office hysteroscopy procedure with a diagnostic purpose
- Must be nulliparous
Key exclusion criteria (3 listed)
- Multiparous women
- Previous cesarean section
- Cervical stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light physics enhanced 'no-touch' hysteroscopyThe 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. | Procedure or surgery | No-touch technique with the application of light physics rules |
| Standard hysteroscopyAnatomical 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 | Procedure or surgery | Control |
Primary outcome
Procedural Pain
Time frame: immediately after the procedure
The visual analogue scale score for procedural pain (0 to 10, 10 as the most painful)
Procedure time
Time frame: procedure
The time required to perform the hysteroscopy
1 secondary outcome
Patient satisfaction
Time frame: immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huseyin Kiyak, MD principal investigator
University of Health Sciences, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light physics enhanced 'no-touch' hysteroscopy and Standard hysteroscopy in people with Infertility, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Pain (time frame: immediately after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.