Serrated LesionNCT03856957
Serrated Lesions Detection With Endocuff-assisted Colonoscopy
A study testing Endocuff colonoscopy in people with Serrated Lesion and Adenoma, run by Hospital Beatriz Ângelo at 1 site in Portugal.
Trial summary
Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Serrated Lesion, Adenoma, Colorectal Cancer
- What is being tested?
- Endocuff colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Jun 2018to 1 Jul 2019
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients undergoing elective colonoscopies
Who cannot join
- Known polyposis syndromes
- Personal colorectal cancer history
- Previous colorectal surgery
- Severe diverticulosis
- Colonic stricture
- Inflammatory bowel disease
- Primary sclerosing cholangitis
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.
- Conditions
- Serrated Lesion, Adenoma, Colorectal Cancer
- Being tested
- Endocuff colonoscopy, control
- Keywords
- Serrated Lesion, Endocuff, Detection
- Medical subject headings
- Adenoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff colonoscopyDevice
Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
controlDevice
colonoscopy without endocuff
| Study group | Role | What they receive |
|---|---|---|
| Endocuff colonoscopy | Experimental | Colonoscopy performed with Endocuff Receives: Device: Endocuff colonoscopy |
| Conventional colonoscopy | Placebo comparator | Colonoscopy performed without any device Receives: Device: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Measured: immediate
Secondary outcomes (9)
Serrated lesions detection rate
Number of patients with at least one serrated lesion/total number of participants
Measured: immediate
Average number of serrated lesions < 10 mm detected per colonoscopy
Average number of serrated lesions < 10 mm detected per colonoscopy
Measured: immediate
Average number of adenomas detected per colonoscopy
Average number of adenomas detected per colonoscopy
Measured: immediate
Adenoma detection rate
Number of patients with at least one adenoma/total number of participants
Measured: immediate
Adenocarcinoma detection rate
Number of patients with at least one adenocarcinoma/total number of participants
Measured: immediate
Cecal intubation rate
Proportion of colonoscopies with cecal intubation x100
Measured: immediate
Cecal incubation time
time from the rectum to cecum in minutes
Measured: immediate
Withdrawal time
time from the cecum to the rectum in minutes
Measured: immediate
Incidence of procedure related adverse events
Number of adverse events
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Jun 2018
- Primary completion30 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serrated LesionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Ferreira, Hospital Beatriz Ângelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856957
- Sponsor's protocol ID
- 0304
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03856957
- Acronym / sponsor ID
- 0304
- Conditions
- Serrated Lesion, Adenoma, Colorectal Cancer
- Keywords
- Serrated Lesion, Endocuff, Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 27 Feb 2019 (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.
Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocuff colonoscopy | Experimental | Device: Endocuff colonoscopyColonoscopy performed with Endocuff |
| Conventional colonoscopy | Placebo comparator | Device: controlColonoscopy performed without any device |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients undergoing elective colonoscopies
Key exclusion criteria (8 listed)
- Known polyposis syndromes
- Personal colorectal cancer history
- Previous colorectal surgery
- Severe diverticulosis
- Colonic stricture
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 colonoscopyColonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy). | Device | Endocuff colonoscopy |
| controlcolonoscopy without endocuff | Device | Conventional colonoscopy |
Primary outcome
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Time frame: immediate
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
9 secondary outcomes
Serrated lesions detection rate
Time frame: immediate
Average number of serrated lesions < 10 mm detected per colonoscopy
Time frame: immediate
Average number of adenomas detected per colonoscopy
Time frame: immediate
Adenoma detection rate
Time frame: immediate
Adenocarcinoma detection rate
Time frame: immediate
Cecal intubation rate
Time frame: immediate
Cecal incubation time
Time frame: immediate
Withdrawal time
Time frame: immediate
Incidence of procedure related adverse events
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 colonoscopy in people with Serrated Lesion and Adenoma, run by Hospital Beatriz Ângelo at 1 site in Portugal.
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 8 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: finished, as of the sponsor's last update on 16 Feb 2021. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average number of serrated lesions ≥ 10 mm detected per colonoscopy (time frame: immediate). 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 16 Feb 2021.