Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Adenocarcinoma Clinical Trial

— CLEAN-MARGIN  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032044
• Other study ID #: MKT-2009-BE-01
• Status: Completed
• Phase: N/A
• First received: December 11, 2009
• Last updated: June 4, 2012
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Mauna Kea Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardFrance: Comité de Protection des PersonnesUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barrett Syndrome
• Barrett's Esophagus
• Barrett's Syndrome
• Syndrome

Intervention

Device:
• Standard endoscopic treatment of BE
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
• pCLE guided endoscopic treatment of BE
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Nantes
United Kingdom	University College London Hospital	London
United States	University of Chicago Hospital	Chicago	Illinois
United States	Mayo Clinic	Jacksonville	Florida
United States	Veterans Affairs Hospital	Kansas City	Missouri
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Mauna Kea Technologies	Cellvizio Inc.

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome of "optimally treated" BE patients 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.		3 month follow-up endoscopic procedure	No