Adenomatous PolypsNCT02374515
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.
A study testing EndoCuff-assisted colonoscopy and Standard Colonoscopy in people with Adenomatous Polyps, run by University of Naples at 1 site in Italy.
Trial summary
This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- EndoCuff-assisted colonoscopy and Standard Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Mar 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colonoscopy: Screening , Surveillance, Diagnostic
Who cannot join
- Pregnancy
- age<18 years
- age > 80 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.
This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.
Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.
- Conditions
- Adenomatous Polyps
- Being tested
- EndoCuff-assisted colonoscopy, Standard Colonoscopy
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoCuff-assisted colonoscopyDevice
Also called EC-assisted colonoscopy
Adenoma detection rate
Standard ColonoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Endocuff assisted Colonoscopy | Active comparator | Endocuff assisted Colonoscopy Receives: Device: EndoCuff-assisted colonoscopy |
| Standard Colonoscopy | Active comparator | Standard colonoscopy Receives: Device: Standard Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Measured: 20 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Domenico De Palma, Federico II University
- Investigators
- Giovanni D. De Palma, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374515
- Sponsor's protocol ID
- 230/14
- Status last verified
- Jun 2016
- First submitted
- 23 Feb 2015
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.
- ClinicalTrials.gov ID
- NCT02374515
- Acronym / sponsor ID
- 230/14
- Conditions
- Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2015 (estimated)
- 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.
This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.
Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocuff assisted Colonoscopy | Active comparator | Device: EndoCuff-assisted colonoscopyEndocuff assisted Colonoscopy |
| Standard Colonoscopy | Active comparator | Device: Standard ColonoscopyStandard colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colonoscopy: Screening , Surveillance, Diagnostic
Key exclusion criteria (6 listed)
- Pregnancy
- age<18 years
- age > 80 years
- known colonic strictures
- chronic inflammatory bowel disease
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-assisted colonoscopyAlso: EC-assisted colonoscopyAdenoma detection rate | Device | Endocuff assisted Colonoscopy |
| Standard Colonoscopy | Device | Standard Colonoscopy |
Primary outcome
adenoma detection rate
Time frame: 20 min.
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 15 Jun 2016.
Related trials for Adenomatous Polyps
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
Recruiting
White Light, TXI, NBI and Computer-Aided Detection for Recurrence at Post-EMR Scars (PRINCESS)
Colorectal Polyps
Recruiting
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Colorectal Cancer, Colorectal Polyp
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
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.
Giovanni D. De Palma, MD principal investigator
Federico II University
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-assisted colonoscopy and Standard Colonoscopy in people with Adenomatous Polyps, run by University of Naples at 1 site in Italy.
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 6 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 15 Jun 2016. 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 Italy. 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?
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?
adenoma detection rate (time frame: 20 min.). 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 15 Jun 2016.