Colonic PolypEFOVNCT06483503
Extra Wide Field of View Lens Study
An observational study of Colonic Polyp, run by Pentax Medical at 1 site in Germany.
Trial summary
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- EFOV Colonoscope
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 21 Aug 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.
Who may be able to join
- Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.
- Signed informed consent.
Who cannot join
- ASA classification ≥3.
- Age <18 years.
- Known or suspicion of inflammatory bowel disease.
- Known polyp(s) for polypectomy.
- High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease.
- Prior colorectal surgery.
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- Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems.
- Unable or unwilling to undergo bowel cleansing for colonoscopy.
- Female patients who are pregnant or nursing.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
RKM 740 Interdisciplinary Care Clinic - Gastroenterology
Düsseldorf
About this study
Official title: A Prospective Cohort Study Evaluating a Novel Colonoscope With a 230-degree Extra-wide Field of View Optics (EFOV)
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.
Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
- Conditions
- Colonic Polyp
- Being tested
- EFOV Colonoscope
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFOV ColonoscopeDevice
Routine colonoscopy using the EFOV lens in the colonoscope.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal Intubation Rate
The proportion of procedures in which the cecum was reached.
Measured: Day 1
Secondary outcomes (7)
Procedure Time
Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time.
Measured: Day 1
Ileum Intubation Rate
Success rate of reaching the Ileum.
Measured: Day 1
Therapeutic Intervention Success Rate
The ability to collect a biopsy or remove a polyp.
Measured: Day 1
Mean number of polyps per coloscopy and its detection rate
Count of number of polyps seen during colonoscopy
Measured: Day 1
Mean number of adenomas and its detection rate
Count of number of adenomas/sessile serrate lesions defined by pathology
Measured: Day 14
Mean number of sessile serrate lesions and its detection rate
Count of number of adenomas/sessile serrate lesions defined by pathology
Measured: Day 14
Patient Satisfaction Survey
During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start21 Aug 2024
- Primary completion8 Dec 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pentax Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horst Neuhaus, MD, PhD, Principal investigator, RKM 740 Interdisciplinary Specialist Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483503
- Sponsor's protocol ID
- CA-PE-EFOV-2024-001 - V1.0
- Acronym
- EFOV
- Status last verified
- Jan 2025
- First submitted
- 18 Jun 2024
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Evaluating a Novel Colonoscope With a 230-degree Extra-wide Field of View Optics (EFOV)
- ClinicalTrials.gov ID
- NCT06483503
- Acronym / sponsor ID
- EFOV / CA-PE-EFOV-2024-001 - V1.0
- Conditions
- Colonic Polyp
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pentax MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 3 Jul 2024 (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.
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.
Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.
Key inclusion criteria (2 listed)
- Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance.
- Signed informed consent.
Key exclusion criteria (10 listed)
- ASA classification ≥3.
- Age <18 years.
- Known or suspicion of inflammatory bowel disease.
- Known polyp(s) for polypectomy.
- High risk for colorectal cancer, history of extensive polyposis, patients with known genetic 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 |
|---|---|---|
| EFOV ColonoscopeRoutine colonoscopy using the EFOV lens in the colonoscope. | Device | – |
Primary outcome
Cecal Intubation Rate
Time frame: Day 1
The proportion of procedures in which the cecum was reached.
7 secondary outcomes
Procedure Time
Time frame: Day 1
Ileum Intubation Rate
Time frame: Day 1
Therapeutic Intervention Success Rate
Time frame: Day 1
Mean number of polyps per coloscopy and its detection rate
Time frame: Day 1
Mean number of adenomas and its detection rate
Time frame: Day 14
Mean number of sessile serrate lesions and its detection rate
Time frame: Day 14
Patient Satisfaction Survey
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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.
Horst Neuhaus, MD, PhD principal investigator
RKM 740 Interdisciplinary Specialist Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp, run by Pentax Medical at 1 site in Germany.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cecal Intubation Rate (time frame: Day 1). 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 10 Jan 2025.