Neoplasms

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Barrett Esophagus

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Standard high-definition white light endoscopy guided evaluation

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

Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard endoscopic evaluation

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.

pCLE guided evaluation

Michael Wallace, MD

Anne Osdoit

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.

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.

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

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

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.

Cellvizio Inc.

Mauna Kea Technologies

Standard high-definition white light endoscopy guided treatment

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

Standard Treatment

Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy

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.

pCLE-guided Treatment

Standard high-definition white light endoscopy guided evaluation

Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard Endoscopic Evaluation

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

pCLE guided evaluation: 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.

pCLE-guided Evaluation

Total

Age, Continuous

Sex: Female, Male

Exploratory analysis of the data according to the intent-to-treat principle resulted in no suggestion of systematic bias in the two groups regarding withdrawals. Only 1 patient was withdrawn because of intolerance to fluorescein.

Dr Michael B. Wallace

Among the 141 patients who completed the initial procedure, 119 had follow-up visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia	NCT01032044	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Standard endosc... pCLE guided eva...	18 Years -	Mauna Kea Technologies
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia	NCT01032044	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Standard endosc... pCLE guided eva...	18 Years -	Mauna Kea Technologies

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