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CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia (CLEAN-MARGIN)

Primary Purpose

Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard endoscopic evaluation
pCLE guided evaluation
Sponsored by
Mauna Kea Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett Syndrome focused on measuring Barrett's esophagus, EsoGastroDuodenoscopy, Barrett's carcinoma, adenocarcinoma, Cellvizio, endomicroscopy, probe-based Confocal Laser Endomicroscopy, pCLE, Radio-frequency ablation, Endoscopic mucosal resection, Photodynamic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Mayo Clinic
  • University of Chicago Hospital
  • Veterans Affairs Hospital
  • University of Washington Medical Center
  • Centre Hospitalier Universitaire
  • University College London Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard endoscopic evaluation

pCLE-guided evaluation

Arm Description

Standard high-definition white light endoscopy guided evaluation

Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2009
Last Updated
March 22, 2016
Sponsor
Mauna Kea Technologies
Collaborators
Cellvizio Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01032044
Brief Title
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Acronym
CLEAN-MARGIN
Official Title
Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mauna Kea Technologies
Collaborators
Cellvizio Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Radio-frequency ablation, Endoscopic mucosal resection, Photodynamic therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard endoscopic evaluation
Arm Type
Active Comparator
Arm Description
Standard high-definition white light endoscopy guided evaluation
Arm Title
pCLE-guided evaluation
Arm Type
Experimental
Arm Description
Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
Intervention Type
Device
Intervention Name(s)
Standard endoscopic evaluation
Intervention Description
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
Intervention Type
Device
Intervention Name(s)
pCLE guided evaluation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
Description
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.
Time Frame
3 month follow-up endoscopic procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wallace, MD
Organizational Affiliation
Mayo Clinic Jacksonville, Florida, United States
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Osdoit
Organizational Affiliation
Mauna Kea Technologies, Paris, France
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Veterans Affairs Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Centre Hospitalier Universitaire
City
Nantes
Country
France
Facility Name
University College London Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22749368
Citation
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.
Results Reference
derived

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CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

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