Cancer of Digestive SystemPERSEENCT02312167
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
A study testing confocal laser endomicroscopy in people with Cancer of Digestive System and Ovarian Cancer, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE). Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Digestive System, Ovarian Cancer
- What is being tested?
- confocal laser endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Oct 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
- patient able to give written informed consent
Who cannot join
- allergy to fluorescein
- allergy to patented blue
- allergy to ICG
- previous life-threatening allergic reactions and known hypersensitivity
- pregnancy or breast-feeding
- history of cardio-pulmonary disease (including bronchial asthma)
Show all 9Show fewer
- restricted renal function
- patient under a beta-blockers treatment
- patient who cannot give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE
This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).
Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.
The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.
Read the detailed description
This study involves several innovations including :
- the robotization of the confocal miniprobe for a better an d more precise handling of the probe
- the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
- the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images
- Conditions
- Cancer of Digestive System, Ovarian Cancer
- Being tested
- confocal laser endomicroscopy
- Keywords
- endomicroscopy, optical biopsy, exploratory surgery, resection surgery, robot-assisted, peritoneum carcinosis, inflammatory, rectum cancer, liver cancer, ovarian cancer, digestive cancer, pancreas cancer, duodenum cancer
- Medical subject headings
- Digestive System Neoplasms, Ovarian Neoplasms, Rectal Neoplasms, Liver Neoplasms, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
confocal laser endomicroscopyDevice
Also called optical biopsy, Cellvizio
probe-based and needle-based confocal laser endomicroscopy
| Study group | Role | What they receive |
|---|---|---|
| confocal laser endomicroscopy | Experimental | confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs Receives: Device: confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events, their type and severity
Measured: 8 months
Secondary outcomes (1)
The ease of manipulation of the robotized probe (grade 1 to 5)
during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of Digestive SystemStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Mauna Kea Technologies
- Responsible party
- Sponsor
- Investigators
- Brice GAYET, MD, Principal investigator, Mutualiste Montsouris Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312167
- Sponsor's protocol ID
- MKT-2013-PERSEE-01
- Acronym
- PERSEE
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2014
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19.
PubMed 30232616
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE
- ClinicalTrials.gov ID
- NCT02312167
- Acronym / sponsor ID
- PERSEE / MKT-2013-PERSEE-01
- Conditions
- Cancer of Digestive System, Ovarian Cancer
- Keywords
- endomicroscopy, optical biopsy, exploratory surgery, resection surgery, robot-assisted, peritoneum carcinosis, inflammatory, rectum cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Mauna Kea Technologies
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Dec 2014 (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.
This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).
Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.
The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.
Detailed description
This study involves several innovations including :
- the robotization of the confocal miniprobe for a better an d more precise handling of the probe
- the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
- the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| confocal laser endomicroscopy | Experimental | Device: confocal laser endomicroscopyconfocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
- patient able to give written informed consent
Key exclusion criteria (9 listed)
- allergy to fluorescein
- allergy to patented blue
- allergy to ICG
- previous life-threatening allergic reactions and known hypersensitivity
- pregnancy or breast-feeding
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 |
|---|---|---|
| confocal laser endomicroscopyAlso: optical biopsy, Cellvizioprobe-based and needle-based confocal laser endomicroscopy | Device | confocal laser endomicroscopy |
Primary outcome
The number of participants with adverse events, their type and severity
Time frame: 8 months
1 secondary outcome
The ease of manipulation of the robotized probe (grade 1 to 5)
Time frame: 8 months
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 11 Feb 2016.
- Derived from this study: PubMed 30232616Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19.
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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.
Brice GAYET, MD principal investigator
Mutualiste Montsouris Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing confocal laser endomicroscopy in people with Cancer of Digestive System and Ovarian Cancer, run by Institut Mutualiste Montsouris at 1 site in France.
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 9 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 11 Feb 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 France. 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?
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?
The number of participants with adverse events, their type and severity (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312167, which also lists 1 linked publication.
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 11 Feb 2016.