ColitisNCT00518349

Colonoscope Passive Bending Function

A study testing Passive bending function and No passive bending function in people with Colitis and Adenoma, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colitis, Adenoma, Carcinoma
What is being tested?: Passive bending function and No passive bending function
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteNorway
Study dates: Aug 2003to Dec 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients referred for routine outpatients colonoscopy

Who cannot join

Pregnant women
Age below 18 years

Trial locations and contacts

1 site in 1 country.

Norway1 site

Gastroenterology section, Dept. of Medicine, Telemark Hospital
Skien, 3710

Other trials in Norway

About this study

Official title: Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study

A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Read the detailed description

Results from the first prototype evaluation has been published.Modifications are presently evaluated.

Conditions: Colitis, Adenoma, Carcinoma, Functional Colonic Disease
Being tested: Passive bending function, No passive bending function
Medical subject headings: Colitis, Adenoma, Carcinoma, Colonic Diseases, Functional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Passive bending functionDevice
Also called passive bending colonoscope
Colonoscope with a passive bending function
No passive bending functionDevice
Also called standard colonoscope
Examination using standard colonoscope without passive bending function

Study groups in NCT00518349
Study group	Role	What they receive
Prototype colonoscope	Active comparator	Colonoscopy using prototype colonoscope with passive bending function Receives: Device: Passive bending function
Standard colonoscope	Placebo comparator	Colonoscopy using standard colonoscope with no passive bending function Receives: Device: No passive bending function

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Assessment of Pain Experienced During Colonoscopy
The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).
Measured: Pain experienced during colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Dec 2009

First posted20 Aug 2007 (estimated)
Study startAug 2003
Primary completionDec 2007
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00518349
Sponsor's protocol ID: ST161006
Status last verified: Sep 2017
First submitted: 17 Aug 2007
Last updated: 29 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hoff G, Moritz V, Bretthauer M, Ludolph T, Huppertz-Hauss G, Paulsen J, Seip B, Sauar J, Kjellevold O, Chengarov L. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study. Scand J Gastroenterol. 2011 Jan;46(1):104-8. doi: 10.3109/00365521.2010.521891. Epub 2010 Oct 6.
PubMed 20923378
Hoff G, Bretthauer M, Huppertz-Hauss G, Sauar J, Paulsen J, Dahler S, Kjellevold O. Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study. Endoscopy. 2005 Nov;37(11):1123-6. doi: 10.1055/s-2005-870444.
PubMed 16281143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Novel Colonoscope Designed for Easier Passage Through Flexures: A Randomised Study
ClinicalTrials.gov ID: NCT00518349
Acronym / sponsor ID: ST161006
Conditions: Colitis, Adenoma, Carcinoma, Functional Colonic Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Norwegian Department of Health and Social AffairsOther government
Collaborators: Sykehuset Telemark
Study start: Aug 2003
Primary completion: Dec 2007 (actual)
Study completion: Dec 2009 (actual)
First posted: 20 Aug 2007 (estimated)
Results: Posted 29 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A prototype colonoscope with an extra passively bending distal section has been developed by Olympus Japan (ref. publications). The present study (2006-2007) is testing refinements of this function.

Detailed description

Results from the first prototype evaluation has been published.Modifications are presently evaluated.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Prototype colonoscope	Active comparator	Device: Passive bending functionColonoscopy using prototype colonoscope with passive bending function
Standard colonoscope	Placebo comparator	Device: No passive bending functionColonoscopy using standard colonoscope with no passive bending function

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients referred for routine outpatients colonoscopy

Key exclusion criteria (2 listed)

Pregnant women
Age below 18 years

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
Passive bending functionAlso: passive bending colonoscopeColonoscope with a passive bending function	Device	Prototype colonoscope
No passive bending functionAlso: standard colonoscopeExamination using standard colonoscope without passive bending function	Device	Standard colonoscope

Primary outcome

Patient Assessment of Pain Experienced During Colonoscopy
Time frame: Pain experienced during colonoscopy
The proportion of patients reporting "no pain" when examined with prototype or standard colonoscope, respectively. Pain experienced was assessed by the patient in a questionnaire to be filled in at home on the day after the examination and mailed in a pre-paid envelope to a national quality register (Gastronet).

Results and safety

Results posted to the registry on 29 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prototype Colonoscope	60	60
Standard Colonoscope	60	60

Primary outcome: Patient Assessment of Pain Experienced During Colonoscopy

Time frame: Pain experienced during colonoscopy. Number. Unit: participants

Measure	1 Prototype Colonoscope n = 60	2 Standard Colonoscope n = 60
Value	19	10

Population analysed: Power estimates based on assumption of 20% difference in pain-free examination comparing groups

Adverse events

Time frame: Adverse event registration was based on events observed during the patient's stay in the endoscopy unit and information from a patient report form to be filled in by the patient on the day after the examination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prototype Colonoscope	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Standard Colonoscope	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20923378Hoff G, Moritz V, Bretthauer M, Ludolph T, Huppertz-Hauss G, Paulsen J, Seip B, Sauar J, Kjellevold O, Chengarov L. Colonoscope with a sub-distal hyper-flaccid segment for improved insertion at colonoscopy: a randomized study. Scand J Gastroenterol. 2011 Jan;46(1):104-8. doi: 10.3109/00365521.2010.521891. Epub 2010 Oct 6.
Results publication: PubMed 16281143Hoff G, Bretthauer M, Huppertz-Hauss G, Sauar J, Paulsen J, Dahler S, Kjellevold O. Evaluation of a novel colonoscope designed for easier passage through flexures: a randomized study. Endoscopy. 2005 Nov;37(11):1123-6. doi: 10.1055/s-2005-870444.

Related trials for Colitis

RecruitingPhase 2
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis, Inflammatory Bowel Diseases
Enrolling by invitationPhase 2
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Ulcerative Colitis, Inflammatory Bowel Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Ulcerative Colitis
RecruitingPhase 2
Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis
RecruitingObservational study
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
Inflammatory Bowel Diseases, Crohn Disease

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.

Geir Hoff, MD, PhD principal investigator

Head of Research, Telemark Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Passive bending function and No passive bending function in people with Colitis and Adenoma, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.

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 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: finished, as of the sponsor's last update on 29 May 2018. 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 Norway. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 29 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Assessment of Pain Experienced During Colonoscopy (time frame: Pain experienced during 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 NCT00518349, which also lists 2 linked publications.

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 May 2018.