ColonoscopyNCT03279705
The efficacy of the Integrated Water Jet Channel Colonoscopy in Water Exchange Method
A study testing Water jet channel and Accessory channel in people with Colonoscopy and Colon Disease, run by Chih-wei Tseng at 1 site in Taiwan.
Trial summary
This prospective randomized controlled trial compared integrated water jet channel colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among patients undergoing WE method colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy, Colon Disease
- What is being tested?
- Water jet channel and Accessory channel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2017to 1 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent fully sedative colonoscopy with WE method in the outpatient department
Who cannot join
- Age < 18 years old or > 80 years old
- Without standard colon preparation
- Allergy to meperidine or propofol
- With a history of partial colectomy
- Refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, 62247
About this study
Official title: Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
This prospective randomized controlled trial compared integrated water jet channel colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among patients undergoing WE method colonoscopy.
Read the detailed description
When the WE method colonoscopy were done with the accessory channel for both infusing and suctioning of water. The water had to be suctioned or infused alternatively and increaed the insertion time.
With the new designed endoscopy that integrated a separate water jet channel for infusing water, infusing and suctioning of water can be done at the same time. Besides, water jet pumping system could provide a powerful jet to help us open the collapse lumen and keep an appropriate distance between the mucosa and the lens, thus preventing loss of visualization. It will help the colonoscopist to find the way during insertion.
- Conditions
- Colonoscopy, Colon Disease
- Being tested
- Water jet channel, Accessory channel
- Keywords
- water exchange, water jet channel colonoscopy, colonoscopy, cecal insertion time, adenoma detection rate
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water jet channelDevice
The separate water jet channel was used for infusing water.
Accessory channelDevice
The accessory channel was used for infusing and/or suctioning water
| Study group | Role | What they receive |
|---|---|---|
| Two-channel group | Experimental | The colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel. Receives: Device: Water jet channel; Device: Accessory channel |
| One-channel group | Active comparator | The colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water. Receives: Device: Accessory channel |
What is being measured
The primary outcome is the main question the study is designed to answer.
cecal insertion time
Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 May 2017
- Primary completion1 Apr 2019
- Study completion1 Oct 2019
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 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
- Model description
- A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chih-wei Tseng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chih-wei Tseng, Dalin Tzu Chi General Hospital
- Investigators
- Yu-Hsi Hsieh, Study director, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279705
- Sponsor's protocol ID
- DalinTCGH
- Status last verified
- Oct 2019
- First submitted
- 24 Aug 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tseng CW, Koo M, Hsieh YH. Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial. J Gastroenterol Hepatol. 2020 Sep;35(9):1562-1569. doi: 10.1111/jgh.15043. Epub 2020 Apr 6.
PubMed 32203986
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
- ClinicalTrials.gov ID
- NCT03279705
- Acronym / sponsor ID
- DalinTCGH
- Conditions
- Colonoscopy, Colon Disease
- Keywords
- water exchange, water jet channel colonoscopy, colonoscopy, cecal insertion time, adenoma detection rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chih-wei TsengUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 12 Sep 2017 (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.
This prospective randomized controlled trial compared integrated water jet channel colonoscopy with traditional accessory channel colonoscopy in cecal insertion time among patients undergoing WE method colonoscopy.
Detailed description
When the WE method colonoscopy were done with the accessory channel for both infusing and suctioning of water. The water had to be suctioned or infused alternatively and increaed the insertion time.
With the new designed endoscopy that integrated a separate water jet channel for infusing water, infusing and suctioning of water can be done at the same time. Besides, water jet pumping system could provide a powerful jet to help us open the collapse lumen and keep an appropriate distance between the mucosa and the lens, thus preventing loss of visualization. It will help the colonoscopist to find the way during insertion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 120 patients were allocated into one of two groups by computerized randomization. In group A (Two-channel group), clear water was infused through the water jet channel and dirty water was sucked form the accessy channel. In group B (One-channel group), water exchange was done by using the accessory channel for both infusing and suctioning of water.
| Arm | Type | Receives |
|---|---|---|
| Two-channel group | Experimental | Device: Water jet channel, Device: Accessory channelThe colonoscopy was done with the new designed colonoscopy that integrated a separate water jet channel for infusing water. The dirty water was removed through other accessory channel. |
| One-channel group | Active comparator | Device: Accessory channelThe colonoscopy was done with the traditional colonoscopy. Water exchange was done by using the accessory channel for both infusing and suctioning of water. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Underwent fully sedative colonoscopy with WE method in the outpatient department
Key exclusion criteria (5 listed)
- Age < 18 years old or > 80 years old
- Without standard colon preparation
- Allergy to meperidine or propofol
- With a history of partial colectomy
- Refusal to provide written 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 |
|---|---|---|
| Water jet channelThe separate water jet channel was used for infusing water. | Device | Two-channel group |
| Accessory channelThe accessory channel was used for infusing and/or suctioning water | Device | One-channel group, Two-channel group |
Primary outcome
cecal insertion time
Time frame: 2 hours
Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Derived from this study: PubMed 32203986Tseng CW, Koo M, Hsieh YH. Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial. J Gastroenterol Hepatol. 2020 Sep;35(9):1562-1569. doi: 10.1111/jgh.15043. Epub 2020 Apr 6.
- Individual participant dataSharing planned: No
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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.
Yu-Hsi Hsieh study director
Dalin Tzu Chi General 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 Water jet channel and Accessory channel in people with Colonoscopy and Colon Disease, run by Chih-wei Tseng at 1 site in Taiwan.
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 5 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 Oct 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 insertion time (time frame: 2 hours). 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 NCT03279705, 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 29 Oct 2019.