Oral TissueNCT03004053
Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo
An observational study of Oral Tissue, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Tissue
- What is being tested?
- Reflectance Confocal Microscopy (RCM) endoscope device
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 28 Feb 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head and Neck clinic
Who may be able to join
- Healthy volunteers
- Ability to sign informed consent
- Age ≥ 18 years.
Who cannot join
- Inability to give informed consent.
- Previously known oral disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy."
- Conditions
- Oral Tissue
- Being tested
- Reflectance Confocal Microscopy (RCM) endoscope device
- Keywords
- Reflectance Confocal Microscopy, Normal Oral Tissue, 16-1652
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflectance Confocal Microscopy (RCM) endoscope deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Volunteers will be identified by the Head and Neck Service | 25 volunteers (Part I - 8 volunteers. Part II - 17 volunteers). during the course of 12 months. The volunteers will be imaged with the endoscope, and the images will be evaluated visually and with qualitative (descriptive) statistics. Receives: Device: Reflectance Confocal Microscopy (RCM) endoscope device |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of images with acceptable quality
Each image will be scored either 1 (completely unacceptable), 2 (unacceptable), 3 (possibly acceptable), 4 (acceptable) or 5 (very acceptable) relative to a reference standard The reference standard for appearance of adequate sectioning, resolution and contrast and for detectability of nuclear and cellular features will be the appearance of images and image quality, which we are intimately familiar with, based on the past several years of experience with the existing RCM device for which images of oral mucosa have been well-characterized, well-correlated to histology, and thus are well-understood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral TissueStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Snehal Patel, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004053
- Sponsor's protocol ID
- 16-1652
- Status last verified
- Mar 2022
- First submitted
- 21 Dec 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of a Novel Endoscope for Reflectance Confocal Microscopy of Normal Oral Tissue In Vivo
- ClinicalTrials.gov ID
- NCT03004053
- Acronym / sponsor ID
- 16-1652
- Conditions
- Oral Tissue
- Keywords
- Reflectance Confocal Microscopy, Normal Oral Tissue, 16-1652
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Dec 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 obtain images (pictures) of normal oral tissue, which occur inside the mouth, using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called "reflectance confocal microscopy."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers will be identified by the Head and Neck Service | – | Device: Reflectance Confocal Microscopy (RCM) endoscope device25 volunteers (Part I - 8 volunteers. Part II - 17 volunteers). during the course of 12 months. The volunteers will be imaged with the endoscope, and the images will be evaluated visually and with qualitative (descriptive) statistics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head and Neck clinic
Key inclusion criteria (3 listed)
- Healthy volunteers
- Ability to sign informed consent
- Age ≥ 18 years.
Key exclusion criteria (2 listed)
- Inability to give informed consent.
- Previously known oral disease
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 |
|---|---|---|
| Reflectance Confocal Microscopy (RCM) endoscope device | Device | Volunteers will be identified by the Head and Neck Service |
Primary outcome
number of images with acceptable quality
Time frame: 1 year
Each image will be scored either 1 (completely unacceptable), 2 (unacceptable), 3 (possibly acceptable), 4 (acceptable) or 5 (very acceptable) relative to a reference standard The reference standard for appearance of adequate sectioning, resolution and contrast and for detectability of nuclear and cellular features will be the appearance of images and image quality, which we are intimately familiar with, based on the past several years of experience with the existing RCM device for which images of oral mucosa have been well-characterized, well-correlated to histology, and thus are well-understood.
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 2 Mar 2022.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Snehal Patel, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Tissue, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 2 Mar 2022. 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 United States. 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?
number of images with acceptable quality (time frame: 1 year). 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 2 Mar 2022.