Barrett SyndromeCLEAN-MARGINNCT01032044
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
A study testing Standard endoscopic evaluation and pCLE guided evaluation in people with Barrett Syndrome and Barrett's Syndrome, run by Mauna Kea Technologies at 6 sites in 3 countries.
Trial summary
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE). It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus
- What is being tested?
- Standard endoscopic evaluation and pCLE guided evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Feb 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
- Undergoing any type of endoscopic BE ablation treatment
- <2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
- Age > 18 years
- Ability to provide written, informed consent
Who cannot join
- Participation in another clinical study
- Circumferential BE
- Complete eradication of BE documented by biopsies
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein
- Pregnancy
- Renal insufficiency
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
University of Chicago Hospital
Chicago, Illinois, 60637
Mayo Clinic
Jacksonville, Florida, 32224
Veterans Affairs Hospital
Kansas City, Missouri, 64128
University of Washington Medical Center
Seattle, Washington, 98115
About this study
Official title: Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
Read the detailed description
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
- Conditions
- Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma
- Being tested
- Standard endoscopic evaluation, pCLE guided evaluation
- Keywords
- Barrett's esophagus, EsoGastroDuodenoscopy, Barrett's carcinoma, adenocarcinoma, Cellvizio, endomicroscopy, probe-based Confocal Laser Endomicroscopy, pCLE, Radio-frequency ablation, Endoscopic mucosal resection, Photodynamic therapy
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard endoscopic evaluationDevice
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
pCLE guided evaluationDevice
Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard endoscopic evaluation | Active comparator | Standard high-definition white light endoscopy guided evaluation Receives: Device: Standard endoscopic evaluation |
| pCLE-guided evaluation | Experimental | Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation) Receives: Device: pCLE guided evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.
Measured: 3 month follow-up endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cellvizio Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Wallace, MD, Principal investigator, Mayo Clinic Jacksonville, Florida, United StatesAnne Osdoit, Study director, Mauna Kea Technologies, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032044
- Sponsor's protocol ID
- MKT-2009-BE-01
- Acronym
- CLEAN-MARGIN
- Status last verified
- Mar 2016
- First submitted
- 11 Dec 2009
- Last updated
- 22 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.
PubMed 22749368
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
- ClinicalTrials.gov ID
- NCT01032044
- Acronym / sponsor ID
- CLEAN-MARGIN / MKT-2009-BE-01
- Conditions
- Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma
- Keywords
- Barrett's esophagus, EsoGastroDuodenoscopy, Barrett's carcinoma, adenocarcinoma, Cellvizio, endomicroscopy, probe-based Confocal Laser Endomicroscopy, pCLE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Cellvizio Inc.
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 22 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
Detailed description
It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard endoscopic evaluation | Active comparator | Device: Standard endoscopic evaluationStandard high-definition white light endoscopy guided evaluation |
| pCLE-guided evaluation | Experimental | Device: pCLE guided evaluationEndoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
- Undergoing any type of endoscopic BE ablation treatment
- <2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
- Age > 18 years
- Ability to provide written, informed consent
Key exclusion criteria (7 listed)
- Participation in another clinical study
- Circumferential BE
- Complete eradication of BE documented by biopsies
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein
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 |
|---|---|---|
| Standard endoscopic evaluationTreatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy | Device | Standard endoscopic evaluation |
| pCLE guided evaluationTreatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure. | Device | pCLE-guided evaluation |
Primary outcome
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
Time frame: 3 month follow-up endoscopic procedure
Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22749368Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.
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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.
Michael Wallace, MD principal investigator
Mayo Clinic Jacksonville, Florida, United States
Anne Osdoit study director
Mauna Kea Technologies, Paris, France
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard endoscopic evaluation and pCLE guided evaluation in people with Barrett Syndrome and Barrett's Syndrome, run by Mauna Kea Technologies at 6 sites in 3 countries.
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 5 inclusion and 7 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 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated" (time frame: 3 month follow-up endoscopic procedure). 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 NCT01032044, 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 22 Apr 2016.