ColonoscopyASGENCT03566615
Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
A study testing CAP-straight, CAP-daisy and water in people with Colonoscopy and Polyp of Colon, run by VA Greater Los Angeles Healthcare System at 7 sites in 4 countries.
Trial summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients that require a routine or repeat colonoscopy. There will be three arms in this study: WE water control, water plus Cap-1, and water plus Cap-2. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Polyp of Colon
- What is being tested?
- CAP-straight, CAP-daisy and water
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,630 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Jul 2018to 31 Jan 2023
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female 50-75 yrs of age.
- Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
- Subjects willing to undergo routine screening and surveillance colonoscopy.
Who cannot join
- Patients who decline to provide informed consent.
- Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions.
- Patients know to have prior history of severe diverticulitis/diverticulosis.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Taiwan3 sites, 3 recruiting
- Recruiting
Dalin Tzu Chi General Hospital
Chiayi City, 622
Yu-Hsi Hsieh, MD, hsieh.yuhsi@msa.hinet.net
- Recruiting
Hualien Tzu Chi Hospital
Hualien City
Chi-Tan Hu, MD, chitan.hu@msa.hinet.net
- Recruiting
Evergreen General Hospital
Taipei
Cheng Chiliang, MD
United States2 sites, 2 recruiting
- Recruiting
Sacramento VAMC, VA Northern California Healthcare System
Mather, California, 95655-4200
Andrew Yen, MD, andrew.yen3@va.gov
Joseph W Leung, MD, Joseph.Leung@va.gov
- Recruiting
Veterans Affairs Palo Alto Healthcare System
Palo Alto, California, 94550
Shai Friedland, MD, shai_friedland@yahoo.com
Ramsey Cheung, MD, rcheung@stanford.edu
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, 710032
Yanglin Pan, MD, panyanglin@gmail.com
About this study
Official title: Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
This is a study to compare two different, but normally, used methods of colonoscopy in patients that require a routine or repeat colonoscopy. There will be three arms in this study: WE water control, water plus Cap-1, and water plus Cap-2. The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air inserted into the colon. The study method will use a new accessory, a cap that will fit onto the end of the colonoscope plus water during the procedure. This study will also confirm if using the cap method with water is a better way of detecting polyps in the colon and possibly cancer.
Read the detailed description
This will be a multi-site, multi-national, unblinded investigators, prospective Random Control Trial (RCT). Randomization (WE, WE Cap-1, WE Cap-2) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with three arms (WE, WE Cap-1, WE Cap-2) to see which one is better at detecting adenomas.
Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening or surveillance). Mode of sedation will include unsedated (China, US West Los Angeles VA), minimally sedated (Taiwan), on demand sedation (Italy, Czech Republic, US West Los Angeles VA), conscious sedation (US Sacramento VA and Palo Alto VA) or full sedation with propofol (Taiwan). Randomization (prepared by statistics consultant) will be carried out by the method of random permuted block design (based on computer generated random numbers) with variable block sizes of 3 and 6. Gender will be used as a stratification factor.
Control Method: One arm of the study will include sedated/unsedated colonoscopy with water (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Study method: The other two arms entail the addition of a simple commercially available accessory to the colonoscopy device: Cap -1 (Disposable Distal Attachment) or Cap-2, fitted to the colonoscope per manufacturer instruction. The two arms include sedated/unsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water.
- Conditions
- Colonoscopy, Polyp of Colon
- Being tested
- CAP-straight, CAP-daisy, water
- Keywords
- colonoscopy, adenoma detection rate, caps
- Medical subject headings
- Colonic Polyps, Cryopyrin-Associated Periodic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAP-straightDevice
This study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
CAP-daisyDevice
This study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
waterOther
using water instead of traditional air insufflation to help insertion
| Study group | Role | What they receive |
|---|---|---|
| Water | Active comparator | Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Receives: Other: water |
| CAP-straight | Experimental | A straight transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Receives: Device: CAP-straight; Other: water |
| CAP-daisy | Experimental | A daisy cap transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Note:
IRB Approval date for the use of Endocuff at St. Barbara Hospital, Iglesias (CA), Italy, was obtained on 3/8/2017.
IRB Approval date for the use of Endocuff at Evergreen General Hospital, Taipei, Taiwan, was obtained on 3/18/2021. Receives: Device: CAP-daisy; Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected.
Measured: 2 years
Secondary outcomes (5)
Cecal intubation
Visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum
Measured: 2 hours: Data collected during colonoscopy procedure
Boston bowel preparation score
Three segments (Right, transverse, left colon), each with 0 to 3 (poor to excellent); total scores = sum (10 point scale)
Measured: 2 hours: Data collected during colonoscopy procedure
Cecal intubation time
Total time from insertion into the anus to arrival in the cecum
Measured: 2 hours: Data collected during colonoscopy procedure
Visual analogue scale (0=not satisfied, 10=very satisfied)
Patient satisfaction
Measured: 2 hours: Data collected during colonoscopy procedure
Willing to repeat
Visual analogue scale (0=not willing, 10=willing)
Measured: 2 hours: Data collected during colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Felix W. Leung, VA Greater Los Angeles Healthcare System
- Investigators
- Felix W Leung, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566615
- Sponsor's protocol ID
- ASGE 2016 International Award
- Acronym
- ASGE
- Status last verified
- Oct 2022
- First submitted
- 30 Apr 2018
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
- ClinicalTrials.gov ID
- NCT03566615
- Acronym / sponsor ID
- ASGE / ASGE 2016 International Award
- Conditions
- Colonoscopy, Polyp of Colon
- Keywords
- colonoscopy, adenoma detection rate, caps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,630 participants (estimated)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- University of California, Los Angeles
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 25 Jun 2018 (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 is a study to compare two different, but normally, used methods of colonoscopy in patients that require a routine or repeat colonoscopy. There will be three arms in this study: WE water control, water plus Cap-1, and water plus Cap-2. The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air inserted into the colon. The study method will use a new accessory, a cap that will fit onto the end of the colonoscope plus water during the procedure. This study will also confirm if using the cap method with water is a better way of detecting polyps in the colon and possibly cancer.
Detailed description
This will be a multi-site, multi-national, unblinded investigators, prospective Random Control Trial (RCT). Randomization (WE, WE Cap-1, WE Cap-2) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with three arms (WE, WE Cap-1, WE Cap-2) to see which one is better at detecting adenomas.
Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening or surveillance). Mode of sedation will include unsedated (China, US West Los Angeles VA), minimally sedated (Taiwan), on demand sedation (Italy, Czech Republic, US West Los Angeles VA), conscious sedation (US Sacramento VA and Palo Alto VA) or full sedation with propofol (Taiwan). Randomization (prepared by statistics consultant) will be carried out by the method of random permuted block design (based on computer generated random numbers) with variable block sizes of 3 and 6. Gender will be used as a stratification factor.
Control Method: One arm of the study will include sedated/unsedated colonoscopy with water (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Study method: The other two arms entail the addition of a simple commercially available accessory to the colonoscopy device: Cap -1 (Disposable Distal Attachment) or Cap-2, fitted to the colonoscope per manufacturer instruction. The two arms include sedated/unsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water | Active comparator | Other: waterResidual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. |
| CAP-straight | Experimental | Device: CAP-straight, Other: waterA straight transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. |
| CAP-daisy | Experimental | Device: CAP-daisy, Other: waterA daisy cap transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Note: IRB Approval date for the use of Endocuff at St. Barbara Hospital, Iglesias (CA), Italy, was obtained on 3/8/2017. IRB Approval date for the use of Endocuff at Evergreen General Hospital, Taipei, Taiwan, was obtained on 3/18/2021. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female 50-75 yrs of age.
- Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
- Subjects willing to undergo routine screening and surveillance colonoscopy.
Key exclusion criteria (3 listed)
- Patients who decline to provide informed consent.
- Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions.
- Patients know to have prior history of severe diverticulitis/diverticulosis.
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 |
|---|---|---|
| CAP-straightThis study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure. | Device | CAP-straight |
| CAP-daisyThis study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure. | Device | CAP-daisy |
| waterusing water instead of traditional air insufflation to help insertion | Other | CAP-daisy, CAP-straight, Water |
Primary outcome
Adenoma detection rate
Time frame: 2 years
The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected.
5 secondary outcomes
Cecal intubation
Time frame: 2 hours: Data collected during colonoscopy procedure
Boston bowel preparation score
Time frame: 2 hours: Data collected during colonoscopy procedure
Cecal intubation time
Time frame: 2 hours: Data collected during colonoscopy procedure
Visual analogue scale (0=not satisfied, 10=very satisfied)
Time frame: 2 hours: Data collected during colonoscopy procedure
Willing to repeat
Time frame: 2 hours: Data collected during colonoscopy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- 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.
Felix W Leung, MD principal investigator
VA Greater Los Angeles Healthcare System
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAP-straight, CAP-daisy and water in people with Colonoscopy and Polyp of Colon, run by VA Greater Los Angeles Healthcare System at 7 sites in 4 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 3 inclusion and 3 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan, United States, China, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivek Dixit, PhD (818-895-9426, vivek.dixit@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 2 years). 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 6 Oct 2022.