ColonoscopyPCCENCT01480635
PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
An observational study of Colonoscopy, run by Bethesda Krankenhaus at 6 sites in Germany.
Trial summary
Purpose of study: To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- How many people
- 74 participants
- Where
- 6 sitesGermany
- Study dates
- Jun 2010to Oct 2012
- Phase
- Observational
- 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
Study population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Who may be able to join
- Subject is >/= 18 years
- Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
- Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum >45 min), adverse reaction to sedation requiring termination of colonoscopy
Who cannot join
- Subject has dysphagia or any swallowing disorder
- Subject has severe congestive heart failure or renal insufficiency
- Subject with high risk for capsule retention
- Subject has a cardiac pacemakers or other implanted electromedical devices
- Subject has any allergy or other contraindication to the medications used in the study
- Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
Show all 12Show fewer
- Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
- Colonoscopy had been performed by a physician who has experience of <1000 complete colonoscopies
- Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
- Time interval between incomplete colonoscopy and capsule endoscopy >30 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Ev. Krankenhaus Düsseldorf
Düsseldorf, 40217
Horst Neuhaus, Prof. Dr., +49-211-919 ext. 1605, horst.neuhaus@evk-duesseldorf.de
Horst Neuhaus, Prof. Dr.
- Recruiting
Gastroenterologische Praxis
Düsseldorf, 40227
Michael Philipper, Dr., +49-0211-773024, miphi@ish.de
Michael Philipper, Dr.
- Recruiting
Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1
Frankfurt, 60590
Jörg Albert, PD Dr., +49-69-6301 ext. 5297, J.Albert@med.uni-frankfurt.de
Jörg Albert, PD Dr.
- Recruiting
Bethesda Krankenhaus Bergedorf
Hamburg, Free and Hanseatic City of Hamburg, 21029
Carola Pflueger, +49-40-72554 ext. 1617, pflueger@bkb.info
+49-40-72554 ext. 1201
- Recruiting
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, 22763
Friedrich Hagenmüller, Prof.Dr., +49-40-181881 ext. 8314, f.hagenmüller@asklepios.com
Friedrich Hagenmüller, Prof. Dr.
- Recruiting
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, 67063
Matthias Bechtler, Dr., +49-06215030
Ralf Jakobs, Prof. Dr.
About this study
Official title: Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
Purpose of study:
To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy
Read more
Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects
Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months
Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time
- Conditions
- Colonoscopy
- Keywords
- Incomplete Colonoscopy, Efficacy of PillCam Colon2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Incomplete Colonoscopy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy
Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.
Measured: One week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJun 2010
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bethesda Krankenhaus
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Martin Keuchel, Dr., Principal investigator, Bethesda Krankenhaus Bergedorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480635
- Sponsor's protocol ID
- PV3467
- Acronym
- PCCE
- Status last verified
- Oct 2011
- First submitted
- 13 Oct 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
- ClinicalTrials.gov ID
- NCT01480635
- Acronym / sponsor ID
- PCCE / PV3467
- Conditions
- Colonoscopy
- Keywords
- Incomplete Colonoscopy, Efficacy of PillCam Colon2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Bethesda KrankenhausUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 Nov 2011 (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.
Purpose of study:
To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy
Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects
Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months
Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incomplete Colonoscopy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Key inclusion criteria (3 listed)
- Subject is >/= 18 years
- Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
- Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum >45 min), adverse reaction to sedation requiring termination of colonoscopy
Key exclusion criteria (12 listed)
- Subject has dysphagia or any swallowing disorder
- Subject has severe congestive heart failure or renal insufficiency
- Subject with high risk for capsule retention
- Subject has a cardiac pacemakers or other implanted electromedical devices
- Subject has any allergy or other contraindication to the medications used in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy
Time frame: One week follow up
Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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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.
Martin Keuchel, Dr. principal investigator
Bethesda Krankenhaus Bergedorf, Hamburg, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Bethesda Krankenhaus at 6 sites 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 3 inclusion and 12 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 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Martin Keuchel, Dr. (+49-40-72554 ext. 1201, keuchel@bkb.info), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy (time frame: One week follow up). 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 29 Nov 2011.