Gynecological MalignanciesNCT02718209
The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures
A study testing Mid-Infrared Spectroscopy with ATR in people with Gynecological Malignancies, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Malignancies
- What is being tested?
- Mid-Infrared Spectroscopy with ATR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Apr 2018
- 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
- Women with one or more tumors in reproductive system
Who cannot join
- Pregnant women
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
Ilan Bruchim, MD contact
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Ilan Bruchim, MD, ilanb@hy.health.gov.il
About this study
The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.
- Conditions
- Gynecological Malignancies
- Being tested
- Mid-Infrared Spectroscopy with ATR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-Infrared Spectroscopy with ATRDevice
| Study group | Role | What they receive |
|---|---|---|
| Frozen section | Experimental | Frozen sections taken from women operated on for possible gynecologic malignancies. Receives: Device: Mid-Infrared Spectroscopy with ATR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynecological Malignancies Identified in Real Time
Results of Spectroscopy will be compared to frozen section/histopathology findings
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological MalignanciesStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilan Bruchim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718209
- Sponsor's protocol ID
- HYMC-84-15
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures
- ClinicalTrials.gov ID
- NCT02718209
- Acronym / sponsor ID
- HYMC-84-15
- Conditions
- Gynecological Malignancies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- 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 purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frozen section | Experimental | Device: Mid-Infrared Spectroscopy with ATRFrozen sections taken from women operated on for possible gynecologic malignancies. |
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)
- Women with one or more tumors in reproductive system
Key exclusion criteria (2 listed)
- Pregnant women
- Unable to give consent
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 |
|---|---|---|
| Mid-Infrared Spectroscopy with ATR | Device | Frozen section |
Primary outcome
Gynecological Malignancies Identified in Real Time
Time frame: One hour
Results of Spectroscopy will be compared to frozen section/histopathology findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- 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.
Ilan Bruchim, MD contact
Ilan Bruchim, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mid-Infrared Spectroscopy with ATR in people with Gynecological Malignancies, 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 2 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 24 Mar 2016. 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 (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?
Gynecological Malignancies Identified in Real Time (time frame: One hour). 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 24 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.