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

Mauna Kea Technologies

Status: Completed

Conditions: Barrett Syndrome; Barrett Esophagus; Adenocarcinoma; Barrett's Syndrome; Barrett's Esophagus

Treatments: Device: pCLE guided evaluation; Device: Standard endoscopic evaluation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032044

MKT-2009-BE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Standard endoscopic evaluation

Active Comparator group

Description:

Standard high-definition white light endoscopy guided evaluation

Treatment:

Device: Standard endoscopic evaluation

pCLE-guided evaluation

Experimental group

Description:

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

Treatment:

Device: pCLE guided evaluation