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Trial Title:
Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population
NCT ID:
NCT05778851
Condition:
Barrett Esophagus
Conditions: Official terms:
Barrett Esophagus
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Screening
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
EsoGuard result
Description:
Education slide-set EsoGuard and patient cases including EsoGuard result
Arm group label:
A2 Intervention
Arm group label:
B2 Intervention
Arm group label:
C2 Intervention
Summary:
This will be a prospective randomized, controlled, virtual, patient study to measure the
impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy
referral.
The participants will complete two rounds of questions concerning the assessed risk for
BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).
After the first round has been completed, an EsoCheck/EsoGuard educational information
package and the second round of 6 clinical vignettes including EsoGuard results will be
sent.
Detailed description:
This will be a prospective randomized, controlled, virtual, patient study to measure the
impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy
referral.
Around 200 US physicians will be asked to participate in this study and at least 100 will
be enrolled. Physicians eligible for participation are those whose scope of practice
includes preventative care and disease screening - namely screening of BE, such as
primary care physicians, family medicine physicians, and general practitioners;
physicians whose scope of practice include diagnosis and management of esophageal disease
may also participate.
The participants will complete two rounds of questions concerning the assessed risk for
BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per
round, there will be 3 different questionnaires consisting of 6 clinical vignettes
(A/B/C). Participants will be randomized to questionnaire A, B or C according to the
randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard
educational information package and the second round of 6 clinical vignettes including
EsoGuard results will be sent.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Board-certified physicians whose scope of practice includes preventative care and
disease screening, and/or those whose scope of practice include diagnosis and
management of esophageal disease (examples include but are not limited to primary
care physicians/ general practitioners, family medicine physicians,
gastroenterologists, and foregut surgeons);
2. Have between 1 to 40 years of post-residency clinical experience within their field
of practice;
3. Have an active panel (whether as part of a group practice, or individually) of over
1000 patients with an adult patient load of more than 50%.
Exclusion Criteria:
- None
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Lucid Diagnostics
Address:
City:
New York
Zip:
10017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria T Lee, MD
Phone:
425-218-6535
Email:
VTL@pavmed.com
Start date:
April 12, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Lucid Diagnostics, Inc.
Agency class:
Industry
Collaborator:
Agency:
Medex15
Agency class:
Industry
Source:
Lucid Diagnostics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05778851
