ColonoscopyNCT01547247
Cap-assisted Water Immersion Versus Water Immersion Colonoscopy
A study testing soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope and water immersion colonoscopy in people with Colonoscopy, run by Vitkovice Hospital at 1 site in Czechia.
Trial summary
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope and water immersion colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2012to Jun 2012
- 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
- outpatient diagnostic colonoscopy
- bowel prep with macrogolum
- initial 2 mg of midazolam i.v.
- signed informed consent form
Who cannot join
- planned therapeutic intervention
- colorectal surgery in history
- known inflammatory bowel disease or colorectal cancer
- refusal of sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.
- Conditions
- Colonoscopy
- Being tested
- soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope, water immersion colonoscopy
- Keywords
- colonoscopy, cap-assisted colonoscopy, water immersion colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscopeDevice
Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
water immersion colonoscopyProcedure or surgery
Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| cap-assisted water immersion colonoscopy | Experimental | Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. Receives: Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope |
| water immersion colonoscopy | Active comparator | Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. Receives: Procedure: water immersion colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal Intubation Time
The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.
Measured: 3 months
Secondary outcomes (2)
Patient Comfort During Insertion Phase of the Colonoscopy
Measured: 3 months
Success Rate of Minimal Sedation Colonoscopy
A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionJun 2012
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 (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitkovice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premysl Falt MD, Vitkovice Hospital
- Investigators
- Premysl Falt, MD, Principal investigator, Digestive Diseases Center, Vitkovice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547247
- Sponsor's protocol ID
- DDC VN 03
- Status last verified
- Oct 2015
- First submitted
- 26 Feb 2012
- Last updated
- 23 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Falt P, Smajstrla V, Fojtik P, Liberda M, Kliment M, Tvrdik J, Urban O. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc. 2013 Jul;25(4):434-9. doi: 10.1111/j.1443-1661.2012.01402.x. Epub 2012 Dec 5.
PubMed 23808948
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
- ClinicalTrials.gov ID
- NCT01547247
- Acronym / sponsor ID
- DDC VN 03
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, cap-assisted colonoscopy, water immersion colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Vitkovice HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 28 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cap-assisted water immersion colonoscopy | Experimental | Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscopeCap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
| water immersion colonoscopy | Active comparator | Procedure: water immersion colonoscopyStandard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- outpatient diagnostic colonoscopy
- bowel prep with macrogolum
- initial 2 mg of midazolam i.v.
- signed informed consent form
Key exclusion criteria (4 listed)
- planned therapeutic intervention
- colorectal surgery in history
- known inflammatory bowel disease or colorectal cancer
- refusal of sedation
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 |
|---|---|---|
| soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscopeColonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal. | Device | cap-assisted water immersion colonoscopy |
| water immersion colonoscopyColonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal. | Procedure or surgery | water immersion colonoscopy |
Primary outcome
Cecal Intubation Time
Time frame: 3 months
The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.
2 secondary outcomes
Patient Comfort During Insertion Phase of the Colonoscopy
Time frame: 3 months
Success Rate of Minimal Sedation Colonoscopy
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23808948Falt P, Smajstrla V, Fojtik P, Liberda M, Kliment M, Tvrdik J, Urban O. Cap-assisted water immersion for minimal sedation colonoscopy: prospective, randomized, single-center trial. Dig Endosc. 2013 Jul;25(4):434-9. doi: 10.1111/j.1443-1661.2012.01402.x. Epub 2012 Dec 5.
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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.
Premysl Falt, MD principal investigator
Digestive Diseases Center, Vitkovice 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 soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope and water immersion colonoscopy in people with Colonoscopy, run by Vitkovice Hospital at 1 site in Czechia.
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 4 inclusion and 4 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 23 Oct 2015. 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 Czechia. 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?
Yes. Results are posted in the registry (first posted 28 Jan 2013). 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?
Cecal Intubation Time (time frame: 3 months). 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 NCT01547247, 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 23 Oct 2015.