Ulcerative ColitisNCT00659867
Endomicroscopy in Ulcerative Colitis
A study testing PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes in people with Ulcerative Colitis, run by PENTAX Europe GmbH at 5 sites in 2 countries.
Trial summary
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2008to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be available before any trial-related procedures
- Male and female patients aged 18 years and older
- Clinically and histologically verified UC
- Duration or Colitis ulcerosa >8 years (date of first diagnosis)
- Colitis Activity Index ≤ 8
- Activity index of Truelove and Witts: mild
- Ability of subject to understand character and individual consequences of clinical trial
- For women with childbearing potential, adequate contraception.
Who cannot join
- Known intraepithelial neoplasia or colorectal cancer
- Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s)
- Impaired renal function (Creatinine >1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain informed consent
- Active GI Bleeding
- Known allergy to methylene blue or fluorescein
- Participation in other clinical trials within the last 4 weeks
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Charité Campus Benjamin Franklin, Medizinische Klinik I
Berlin, 12200
Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II
Jena, 07740
Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik
Mainz, 55101
Italy2 sites
Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division
Crema, 26013
European Institute of Oncology, Division of Endoscopy
Milan, 20141
About this study
Official title: Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.
- Conditions
- Ulcerative Colitis
- Being tested
- PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
- Keywords
- Ulcerative Colitis, Endomicroscopy, Chromoendoscopy, Confocal colonoscope, Surveillance colonoscopy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopesDevice
Also called Endomicroscope
chromoscopy-guided endomicroscopy with targeted biopsies
PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopesDevice
Also called Endomicroscope
Standard endoscopy with random and targeted biopsies
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Chromoscopy-guided endomicroscopy with targeted biopsies Receives: Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes |
| B | Active comparator | Standard endoscopy with random and targeted biopsies Receives: Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN
Measured: Day 1 (colonoscopy)
Secondary outcomes (1)
Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups.
Measured: Day 1 (colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2015
- Study completionSep 2016
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTAX Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Annette Weissmann, PENTAX Europe GmbH
- Investigators
- Ralf Kiesslich, Prof. Dr., Principal investigator, Johannes Gutenberg-Universität Mainz, I. Med. Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659867
- Sponsor's protocol ID
- 2006-09
- Status last verified
- Sep 2016
- First submitted
- 14 Apr 2008
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hurlstone DP, Kiesslich R, Thomson M, Atkinson R, Cross SS. Confocal chromoscopic endomicroscopy is superior to chromoscopy alone for the detection and characterisation of intraepithelial neoplasia in chronic ulcerative colitis. Gut. 2008 Feb;57(2):196-204. doi: 10.1136/gut.2007.131359.
PubMed 18192453
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00659867
- Acronym / sponsor ID
- 2006-09
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Endomicroscopy, Chromoendoscopy, Confocal colonoscope, Surveillance colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 182 participants (actual)
- Lead sponsor
- PENTAX Europe GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- Dec 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Apr 2008 (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 is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopesChromoscopy-guided endomicroscopy with targeted biopsies |
| B | Active comparator | Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopesStandard endoscopy with random and targeted biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent must be available before any trial-related procedures
- Male and female patients aged 18 years and older
- Clinically and histologically verified UC
- Duration or Colitis ulcerosa >8 years (date of first diagnosis)
- Colitis Activity Index ≤ 8
Key exclusion criteria (8 listed)
- Known intraepithelial neoplasia or colorectal cancer
- Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s)
- Impaired renal function (Creatinine >1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain informed consent
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 |
|---|---|---|
| PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopesAlso: Endomicroscopechromoscopy-guided endomicroscopy with targeted biopsies | Device | A |
| PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopesAlso: EndomicroscopeStandard endoscopy with random and targeted biopsies | Device | B |
Primary outcome
The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN
Time frame: Day 1 (colonoscopy)
1 secondary outcome
Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups.
Time frame: Day 1 (colonoscopy)
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 18192453Hurlstone DP, Kiesslich R, Thomson M, Atkinson R, Cross SS. Confocal chromoscopic endomicroscopy is superior to chromoscopy alone for the detection and characterisation of intraepithelial neoplasia in chronic ulcerative colitis. Gut. 2008 Feb;57(2):196-204. doi: 10.1136/gut.2007.131359.
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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.
Ralf Kiesslich, Prof. Dr. principal investigator
Johannes Gutenberg-Universität Mainz, I. Med. Klinik
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes in people with Ulcerative Colitis, run by PENTAX Europe GmbH at 5 sites in 2 countries.
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 8 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: stopped early, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, 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 was stopped early (reason given: Recruitment problems). Results are not available in the source record.
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?
The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN (time frame: Day 1 (colonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00659867, which also lists 1 linked publication.
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 2016.