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

M

Mauna Kea Technologies

Status

Completed

Conditions

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

Treatments

Device: Standard endoscopic evaluation
Device: pCLE guided 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

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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