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New device could let surgeons see tissues in real time during gynecological surgery

NCT ID NCT04154683

Diagnosis Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests Cellvizio, a device that provides real-time, high-resolution views of tissues during gynecological surgery. Researchers want to see if it can help diagnose lesions and check surgical margins more accurately. The study will enroll 80 women undergoing laparoscopic surgery for conditions like endometriosis or cancer. Results will be compared with standard pathology reports.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cellvizio optical biopsy device
What this could lead to
If successful, this could make diagnosis during gynecological surgery faster and more accurate, reducing the need for traditional biopsies.
What could go wrong
This is a small, early-stage study with only 80 participants, so results may not apply to all patients. The technology may not match standard pathology in accuracy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Jun 2020

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women aged 18 years or more * Informed and signed consent * Planned surgery under laparoscopy and included in the list below: * unilateral or bilateral salpingectomy * hysterectomy * ovariectomy * surgery of endometriosis * surgery for cancer of the cervix, endometrium, ovaries Exclusion Criteria: * Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc. * Pregnancy or desire of pregnancy during the study period, breastfeeding * Hypersensitivity to Fluorescein or any of its excipients * History of life-threatening reaction during angiography * Known allergic reactions and hypersensitivity * Severe asthma, heart and / or lung disease, diabetes * Person on beta-blocker treatment * Inability to understand information provided * Not covered by a national health insurance scheme, prisoner or under administrative supervision

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Conditions

The condition(s) this trial relates to.

cervical cancer endometrial cancer endometriosis ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gynecologic surgical procedures

Contacts and locations

Locations

  • Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

    Bron, 69500, France

  • Service de Gynécologie, HFME, Hospices Civils de Lyon

    Bron, 69500, France

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