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OpenTrials
Completed

NCT Number: NCT05628441

Real-time Computer Aided Detection of Barrett's Neoplasia

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center

Amsterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer Aided Detection system for Barrett's neoplasia

Other

CADe system running in the back, not directly interfering with patient care

Primary outcomes

  1. Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity

    Time frame: 5 months

    To investigate the combined performance between endoscopist and CADe system on a per-patient level.

Secondary outcomes

  1. Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity

    Time frame: 5 months

    To investigate the performance of the CADe system on new data on a per-patient level.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 28, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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