Colon PolypNCT04805567
Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy
An observational study of Colon Polyp and Endocuff, run by Venizelio General Hospital.
Trial summary
Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp, Endocuff
- What is being tested?
- endocuff
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Τhe study is a single center cohort study. Venizeleio General Hospital is a tertiary hospital and the population that will be selected would be residents of the island of Crete.
Who may be able to join
- (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years.
Who cannot join
- (i) age below 50 years; (ii) the presence of significant comorbidities (American Society of Anesthesiologists [ASA] score III or IV); (iv) recent abdominal surgery; (iv) inflammatory bowel disease; (v) colectomy; (vi) polyposis syndrome; (vii) the presence of acute, severe colitis or a known colonic stricture (viii) boston scale bowel preparation ≥6.
Trial locations and contacts
No sites are listed yet.
About this study
Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal.
The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.
- Conditions
- Colon Polyp, Endocuff
- Being tested
- endocuff
- Keywords
- endocuff, tandem colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocuffDevice
The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Patients with polyps and adenomas | The inclusion criteria are: (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years. Receives: Device: endocuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
of Endocuff-assisted colonoscopy adenoma and polyp miss rate
The primary outcome is the measurement of Endocuff-assisted colonoscopy adenoma and polyp miss rates, overall and in the proximal colon.
Measured: up to 21 days after the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venizelio General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fragaki, Venizelio General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805567
- Sponsor's protocol ID
- VenizelioGH
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy
- ClinicalTrials.gov ID
- NCT04805567
- Acronym / sponsor ID
- VenizelioGH
- Conditions
- Colon Polyp, Endocuff
- Keywords
- endocuff, tandem colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Venizelio General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 18 Mar 2021 (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.
Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal.
The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with polyps and adenomas | – | Device: endocuffThe inclusion criteria are: (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Τhe study is a single center cohort study. Venizeleio General Hospital is a tertiary hospital and the population that will be selected would be residents of the island of Crete.
Key inclusion criteria (1 listed)
- (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years.
Key exclusion criteria (1 listed)
- (i) age below 50 years; (ii) the presence of significant comorbidities (American Society of Anesthesiologists [ASA] score III or IV); (iv) recent abdominal surgery; (iv) inflammatory bowel disease; (v) colectomy; (vi) polyposis syndrome; (vii) the presence of acute, severe colitis or a known colonic stricture (viii) boston scale bowel preparation ≥6.
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 |
|---|---|---|
| endocuffThe Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. | Device | Patients with polyps and adenomas |
Primary outcome
of Endocuff-assisted colonoscopy adenoma and polyp miss rate
Time frame: up to 21 days after the colonoscopy
The primary outcome is the measurement of Endocuff-assisted colonoscopy adenoma and polyp miss rates, overall and in the proximal colon.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Colon Polyp
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyp and Endocuff, run by Venizelio General Hospital.
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 1 inclusion and 1 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact MARIA FRAGAKI (+302813408017, mgfragaki@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
of Endocuff-assisted colonoscopy adenoma and polyp miss rate (time frame: up to 21 days after the colonoscopy). 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 18 Mar 2021.