Uterine Cervical NeoplasmNCT03971032
An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure
A study testing Hysteroscopy and Infrared Spectroscopy in people with Uterine Cervical Neoplasm and Uterine Neoplasms, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasm, Uterine Neoplasms
- What is being tested?
- Hysteroscopy and Infrared Spectroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Dec 2019to May 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hysteroscopy
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Ilan Bruchim, MD, ilanb@hy.health.gov.il
Ilan Bruchim, MD
About this study
Official title: A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy
The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.
- Conditions
- Uterine Cervical Neoplasm, Uterine Neoplasms
- Being tested
- Hysteroscopy, Infrared Spectroscopy
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
Diagnostic procedure
Infrared SpectroscopyDevice
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing hysteroscopy | Other | Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy Receives: Procedure: Hysteroscopy; Device: Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of infrared spectroscopy with routine histopathology
Tissue smears that have undergone infrared spectroscopy during hysteroscopy will have a different spectral absorption than healthy tissue, thus indicating malignancy. These results will be compared to the results of routine histopathology to determine accuracy of spectroscopy to indicate malignancy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start31 Dec 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971032
- Sponsor's protocol ID
- HYMC-0098-18
- Status last verified
- Dec 2019
- First submitted
- 1 May 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy
- ClinicalTrials.gov ID
- NCT03971032
- Acronym / sponsor ID
- HYMC-0098-18
- Conditions
- Uterine Cervical Neoplasm, Uterine Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 31 Dec 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 3 Jun 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.
The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing hysteroscopy | Other | Procedure: Hysteroscopy, Device: Infrared SpectroscopyWomen presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing hysteroscopy
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| HysteroscopyDiagnostic procedure | Procedure or surgery | Women undergoing hysteroscopy |
| Infrared SpectroscopyThis device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy | Device | Women undergoing hysteroscopy |
Primary outcome
Comparison of infrared spectroscopy with routine histopathology
Time frame: 3 years
Tissue smears that have undergone infrared spectroscopy during hysteroscopy will have a different spectral absorption than healthy tissue, thus indicating malignancy. These results will be compared to the results of routine histopathology to determine accuracy of spectroscopy to indicate malignancy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy and Infrared Spectroscopy in people with Uterine Cervical Neoplasm and Uterine Neoplasms, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2019. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Bruchim, MD (972-4-7744335, ilanb@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of infrared spectroscopy with routine histopathology (time frame: 3 years). 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 4 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.