Real-time Computer Aided Detection of Barrett's Neoplasia

Barrett Esophagus Clinical Trial

Official title:

Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628441
• Other study ID #: 2021.0269
• Status: Completed
• Start date: May 16, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: November 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.

Description:

Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15).

Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded.

During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 13, 2022
• Est. primary completion date: October 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age > 18 years;

• Patients under surveillance for their diagnosed non-dysplastic Barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma;

• A circumferential Barrett length of at least 2cm

Exclusion Criteria:

• Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus

• Reflux esophagitis > grade 2 (LA classification)

• Inability to undergo endoscopic treatment and/or biopsies

Related Conditions & MeSH terms

• Barrett Adenocarcinoma
• Barrett Esophagus

Intervention

Other:
• Computer Aided Detection system for Barrett's neoplasia
CADe system running in the back, not directly interfering with patient care

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity	To investigate the combined performance between endoscopist and CADe system on a per-patient level.	5 months
Secondary	Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity	To investigate the performance of the CADe system on new data on a per-patient level.	5 months