AdenomaNCT04107376
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps
A study testing Retroviewing endoscopy in people with Adenoma and Polyps, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Retroviewing endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 30 Sep 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- screening colonoscopy
- 18 years of age
Who cannot join
- inflammatory bowel disease
- inadequate bowel preparation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, 91054
Timo Rath, Professor of Endoscopy, 49 9131 ext. 85 45041, timo.rath@uk-erlangen.de
About this study
During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.
- Being tested
- Retroviewing endoscopy
- Keywords
- retroviewing, endoscopy, adenoma detection, polyp detection
- Medical subject headings
- Adenoma, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroviewing endoscopyDiagnostic test
The colon is inspected with a new retroviewing endoscope
| Study group | Role | What they receive |
|---|---|---|
| Retroviewing endoscopy (RVE) | Experimental | Withdrawal in every colonic segment with SFV (standard forward view) followed by another withdrawal with the retroviewing endoscope. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes. Receives: Diagnostic Test: Retroviewing endoscopy |
| standard forward viewing endoscopy (SFVE) | Active comparator | Withdrawal in every colonic segment with SFV followed by another withdrawal with SFV. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes. Receives: Diagnostic Test: Retroviewing endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
calculation of the adenoma detection rate in each arm
Measured: 8 months
Secondary outcomes (3)
Polyp detection rate
polyp detection rate in each arm
Measured: 8 months
Mean number of adenomas per patient
Mean number of adenomas per patient in each arm
Measured: 8 months
Withdrawal time
Withdrawal time in each arm
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Dec 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Rath, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107376
- Sponsor's protocol ID
- Ludwig Demling Endoscopy
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps
- ClinicalTrials.gov ID
- NCT04107376
- Acronym / sponsor ID
- Ludwig Demling Endoscopy
- Keywords
- retroviewing, endoscopy, adenoma detection, polyp detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 27 Sep 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.
During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retroviewing endoscopy (RVE) | Experimental | Diagnostic Test: Retroviewing endoscopyWithdrawal in every colonic segment with SFV (standard forward view) followed by another withdrawal with the retroviewing endoscope. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes. |
| standard forward viewing endoscopy (SFVE) | Active comparator | Diagnostic Test: Retroviewing endoscopyWithdrawal in every colonic segment with SFV followed by another withdrawal with SFV. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- screening colonoscopy
- 18 years of age
Key exclusion criteria (2 listed)
- inflammatory bowel disease
- inadequate bowel preparation
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 |
|---|---|---|
| Retroviewing endoscopyThe colon is inspected with a new retroviewing endoscope | Diagnostic test | Retroviewing endoscopy (RVE), standard forward viewing endoscopy (SFVE) |
Primary outcome
Adenoma detection rate
Time frame: 8 months
calculation of the adenoma detection rate in each arm
3 secondary outcomes
Polyp detection rate
Time frame: 8 months
Mean number of adenomas per patient
Time frame: 8 months
Withdrawal time
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Adenoma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retroviewing endoscopy in people with Adenoma and Polyps, run by University of Erlangen-Nürnberg Medical School 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 2 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 27 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timo Rath, MD (+49 9131 85 35000, timo.rath@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 8 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 27 Sep 2019.