Colon Cancer ScreeningNCT06116864
Enchasing Polyp Detection: The Effect of Adding Polyp Detection Attachment Device to Computer Aid Detection System.
A study testing Endocuff and GI Genius and GI Genius in people with Colon Cancer Screening and Colon Cancer Surveillance, run by Marshall University at 1 site in United States.
Trial summary
Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer Screening, Colon Cancer Surveillance
- What is being tested?
- Endocuff and GI Genius and GI Genius
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,766 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Patients scheduled for an outpatient screening or surveillance colonoscopy.
Who cannot join
- Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
- Patients requiring deep ileal intubation.
- Patients with inflammatory bowel disease.
- Patients with radiotherapy-induced colitis or other severe colitis.
- Patients with colonic strictures.
- Patients with acute diverticulitis.
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- Patients with large bowel obstruction.
- Patients scheduled for therapeutic colonoscopy (e.g., planned endoscopic mucosal resection for known polyps).
- Patients scheduled for assessment of a known colonic lesion.
- Patients with a known history of hereditary polyposis syndrome or untreated colon cancer.
- Patients with a history of colon resection.
- Patients on continuous anti-thrombotic therapy
- Pregnancy.
- Patients who are ineligible for colonoscopy due to medical or psychiatric conditions.
- Patients who are vulnerable or unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshall University Joan C. Edwards School of Medicine/Cabell Huntington Hospital
Huntington, West Virginia, 25701
About this study
Official title: Enhancing Polyp Detection: A Randomized Controlled Trial Comparing Combined Computer-Aid Detection and Polyp-Detecting Colonoscope Attachment to Computer-Aid Detection Alone in Patients Undergoing Colonoscopy.
Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.
- Conditions
- Colon Cancer Screening, Colon Cancer Surveillance
- Being tested
- Endocuff and GI Genius, GI Genius
- Keywords
- Colon cancer screening, Colon cancer surveillance, Computer-Aided Detection of adenoma, Colonoscope attachment device, Endocuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff and GI GeniusDevice
Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
GI GeniusDevice
GI Genius is and Computer-Aid Detection (CADe) system to detect polyps
| Study group | Role | What they receive |
|---|---|---|
| Endocuff + GI Genius | Experimental | Endocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps Receives: Device: Endocuff and GI Genius |
| GI Genius | Active comparator | GI Genius is and Computer-Aid Detection (CADe) system to detect polyps Receives: Device: GI Genius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
It is the percentage of patients who have at least one adenoma detected during the colonoscopy
Measured: 18 months
Secondary outcomes (9)
Polyp detection rate
Measured: 18 months
Number of cancerous lesions
Measured: 18 months
Differences in polyps histology between the groups
Measured: 18 months
Differences in polyps size
Measured: 18 months
Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)
Measured: 18 months
Cecal intubation rate
Measured: 18 months
Cecal intubation time
Measured: 18 months
Colonoscopy withdrawal time
Measured: 18 months
Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start23 Oct 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,766 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Frandah, Marshall University
- Investigators
- Wesam Frandah, MD, Principal investigator, Marshall University Joan C. Edwards School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116864
- Sponsor's protocol ID
- 2094805
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Polyp Detection: A Randomized Controlled Trial Comparing Combined Computer-Aid Detection and Polyp-Detecting Colonoscope Attachment to Computer-Aid Detection Alone in Patients Undergoing Colonoscopy.
- ClinicalTrials.gov ID
- NCT06116864
- Acronym / sponsor ID
- 2094805
- Conditions
- Colon Cancer Screening, Colon Cancer Surveillance
- Keywords
- Colon cancer screening, Colon cancer surveillance, Computer-Aided Detection of adenoma, Colonoscope attachment device, Endocuff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,766 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the widespread use of colonoscopy, the ongoing challenge of potentially missing polyps remains. Previous studies have independently shown that both Endocuff, a colonoscope attachment device for polyp detection, and Computer-Aided Detection (CADe) systems have individually demonstrated enhanced lesion detection and safety. This study seeks to evaluate the efficacy of combining the Endocuff CADe versus using CADe alone in colonoscopy procedures for colorectal cancer screening and surveillance. This research project aims to ascertain whether the synergistic application of these technologies yields superior outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial that compares Endocuff with Gi Genius (group A) to GI Genius alone (group B) for patients who are undergoing elective outpatient colonoscopy. Patients will be randomized by a secure online randomization software that will allocate patients in a 1:1 ratio to group A or group B.
| Arm | Type | Receives |
|---|---|---|
| Endocuff + GI Genius | Experimental | Device: Endocuff and GI GeniusEndocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps |
| GI Genius | Active comparator | Device: GI GeniusGI Genius is and Computer-Aid Detection (CADe) system to detect polyps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Patients scheduled for an outpatient screening or surveillance colonoscopy.
Key exclusion criteria (15 listed)
- Patients who require diagnostic colonoscopy (e.g.; anemia or GI bleeding).
- Patients requiring deep ileal intubation.
- Patients with inflammatory bowel disease.
- Patients with radiotherapy-induced colitis or other severe colitis.
- Patients with colonic strictures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocuff and GI GeniusEndocuff is a polyp-detecting colonoscope attachment device. GI Genius is and Computer-Aid Detection (CADe) system to detect polyps | Device | Endocuff + GI Genius |
| GI GeniusGI Genius is and Computer-Aid Detection (CADe) system to detect polyps | Device | GI Genius |
Primary outcome
Adenoma detection rate
Time frame: 18 months
It is the percentage of patients who have at least one adenoma detected during the colonoscopy
9 secondary outcomes
Polyp detection rate
Time frame: 18 months
Number of cancerous lesions
Time frame: 18 months
Differences in polyps histology between the groups
Time frame: 18 months
Differences in polyps size
Time frame: 18 months
Polyps location (cecum, ascending, transverse, descending, sigmoid, or rectum)
Time frame: 18 months
Cecal intubation rate
Time frame: 18 months
Cecal intubation time
Time frame: 18 months
Colonoscopy withdrawal time
Time frame: 18 months
Procedure complication (bleeding or perforation) by the end of the procedure. (Following lexicon for endoscopic adverse events methods)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesam Frandah, MD principal investigator
Marshall University Joan C. Edwards School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocuff and GI Genius and GI Genius in people with Colon Cancer Screening and Colon Cancer Surveillance, run by Marshall University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.