Colorectal CancerNCT02041507
Water-aided Colonoscopy vs Air Insufflation Colonoscopy in Colorectal Cancer Screening
A study testing Air insufflation method., Water Immersion method. and Water Exchange method. in people with Colorectal Cancer and Colorectal Adenomas, run by Presidio Ospedaliero Santa Barbara at 4 sites in 3 countries.
Trial summary
The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps
- What is being tested?
- Air insufflation method., Water Immersion method. and Water Exchange method.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,224 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Feb 2014to Apr 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive screening patients
Who cannot join
- previous colonoscopy within 5 years
- surveillance colonoscopy
- previous colorectal surgery
- indication for a proctosigmoidoscopy or bidirectional endoscopy
- history of inflammatory bowel disease
- patient refusal or inability to provide informed consent
- inadequate consumption of bowel preparation
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Italy2 sites
Division of Gastroenterology, Ospedale Valduce
Como, CO, 22100
Digestive Endoscopy Unit, Ospedale S. Barbara
Iglesias, CI, 09016
United States1 site
Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
Los Angeles, California, 91343
About this study
Official title: A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy
The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer.
Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm, P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy.
Read more
Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.
In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the proximal colon.
In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy.
We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy.
Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues.
Several secondary outcomes will also be analysed.
Read the detailed description
Design: Prospective double-blinded multicenter randomized controlled trial. Methods: Colonoscopy with Air Insufflation, Water Immersion, Water Exchange to aid insertion of colonoscope; split dose bowel preparation. Sedation available at the start of the procedure or on-demand.
Control method: Air insufflation colonoscopy. Study methods: Water Immersion colonoscopy, Water Exchange colonoscopy.
Population: Consecutive 50 to 70 year-old screening patients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Primary outcome: overall Adenoma Detection Rate. Secondary outcomes: proximal colon ADR, Mean Adenomas resected per Procedure (MAP), cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), maximum pain during colonoscopy assessed during insertion and at discharge, the need for sedation/analgesia and its dosage. In addition loop reduction maneuvers, position changes, abdominal compression, the amount of infused and suctioned water during insertion and withdrawal, and patients willingness to repeat the examination will be evaluated.
- Conditions
- Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps, Pain
- Being tested
- Air insufflation method., Water Immersion method., Water Exchange method.
- Keywords
- Water-aided colonoscopy, Water Immersion, Water Exchange, On-demand sedation, Unsedated colonoscopy, Adenoma detection rate, Mean adenomas per procedure
- Medical subject headings
- Colorectal Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air insufflation method.Other
Air insufflation colonoscopy.
Water Immersion method.Other
Water Immersion during insertion, air insufflation during withdrawal.
Water Exchange method.Other
Water Exchange during insertion, air insufflation during withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Air insufflation method. | Active comparator | Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure. Receives: Other: Air insufflation method. |
| Water Immersion method. | Experimental | Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Withdrawal phase done using air insufflation. Receives: Other: Water Immersion method. |
| Water Exchange method. | Experimental | Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using air insufflation. Receives: Other: Water Exchange method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate.
Proportion of subjects with at least one adenoma of any size.
Measured: 18 months.
Secondary outcomes (9)
Proximal colon Adenoma Detection Rate.
Proportion of subjects with at least one adenoma of any size in the proximal colon.
Measured: 18 months.
Proximal colon <10 mm Adenoma Detection Rate.
Proportion of subjects with at least one adenoma <10 mm in the proximal colon.
Measured: 18 months.
Mean adenomas resected per procedure.
Total number of adenomas resected per subject.
Measured: 18 months.
Cecal intubation rate.
Cecal intubation will be defined as passage of the tip of the colonoscope beyond the ileocecal valve so that the medial wall of the cecum proximal to the ileocecal valve will be observed.
Measured: 1 hour.
Cecal intubation time.
Cecal intubation time will be defined as the time for passage of the colonoscope from the rectum to the cecum.
Measured: 1 hour.
Total procedure time.
Total procedure time (including time required for polyp resection or biopsy).
Measured: 1 hour.
Maximum pain score recorded during insertion phase of colonoscopy.
Pain will be measured on a visual analogue scale (VAS) with a score 0=absence of pain, 1-2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patient. Patient will be informed that the request for pain information is not to remind that the examination should be uncomfortable, but to let the colonoscopist be alerted to the need to use maneuvers to minimize discomfort (e.g. loop reduction, removal of colonic content, abdominal compression and/or change in patient position). At regular intervals during colonoscopy (e.g. every 60 seconds) patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.
Measured: 1 hour.
Pain score at discharge.
After the procedure and at discharge from the Endoscopy Unit, an assistant nurse blinded to the procedure will ask patients about maximum pain during insertion phase of the procedure using the same VAS when neither the endoscopist nor the assistant nurse who performed the colonoscopy will be present. Patients will be asked to quantify the degree of pain experienced and to place a mark over the VAS accordingly.
Measured: 1 hour.
Need for sedation/analgesia and its dosage
All patients will be offered sedation for the procedure. Patients can accept or decline the medication. If they accept, the procedure will be started with the administration of 2 mg of Midazolam intravenously (minimal sedation). If the patient will choose on-demand sedation, minimal sedation will be offered when pain score reaches ≥2 on the VAS. Patients can accept or decline the offered medication. If they accept, minimal sedation will be administered as described above. To avoid bias by the colonoscopist, sedation medication will be administered based on the patients' confirmation that the pain is no longer tolerable, and not at the discretion of the colonoscopist. The colon segment in which patients requests sedation will be recorded. If additional medication will be required despite the abovementioned maneuvers and/or minimal sedation, it will be provided according to local standards and it will be recorded.
Measured: 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Ospedaliero Santa Barbara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Cadoni, M.D., Presidio Ospedaliero Santa Barbara
- Investigators
- Sergio Cadoni, MD, Principal investigator, S. Barbara Hospital, Iglesias (CI), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041507
- Sponsor's protocol ID
- PI.2013.2502
- Other IDs
- Delibera 1047.2013
- Status last verified
- Apr 2016
- First submitted
- 18 Jan 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
PubMed 22898423Gupta S, Balasubramanian BA, Fu T, Genta RM, Rockey DC, Lash R. Polyps with advanced neoplasia are smaller in the right than in the left colon: implications for colorectal cancer screening. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1395-1401.e2. doi: 10.1016/j.cgh.2012.07.004. Epub 2012 Jul 24.
PubMed 22835574Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11.
PubMed 24218307Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PubMed 20883846Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
PubMed 23931857Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.
PubMed 22987214Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.
PubMed 28282689
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Air Insufflation, Water Immersion and Water Exchange for Adenoma Detection Rate in Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT02041507
- Acronym / sponsor ID
- PI.2013.2502
- Conditions
- Colorectal Cancer, Colorectal Adenomas, Colorectal Polyps, Pain
- Keywords
- Water-aided colonoscopy, Water Immersion, Water Exchange, On-demand sedation, Unsedated colonoscopy, Adenoma detection rate, Mean adenomas per procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,224 participants (actual)
- Lead sponsor
- Presidio Ospedaliero Santa BarbaraUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jan 2014 (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.
The degree of protection afforded by colonoscopy against proximal colorectal cancer (CRC) appears to be related to the quality of the procedure, and the incomplete removal of lesions has been shown to increase the subsequent risk of developing a colon cancer.
Some studies suggest that small polyps with advanced histology are more common in the right than in the left colon (right colon proximal to splenic flexure, left colon distal to the splenic flexure). The average size of polyps in the right colon with advanced pathology or containing adenocarcinoma was ≤9 mm, whereas in the left colon their average size was >9 mm, P<0.001. Inadequate prevention of right-sided CRC incidence and mortality may be due to right-sided polyps with advanced histology or that harbor malignancy. These presumptive precursors of cancer are smaller and possibly more easily obscured by residual feces, and more likely to be missed at colonoscopy.
Water-aided colonoscopy (WAC) can be subdivided broadly into two major categories: water immersion (WI), characterized by suction removal of the infused water predominantly during the withdrawal phase of colonoscopy, and water exchange (WE), characterized by suction removal of infused water predominantly during the insertion phase of colonoscopy.
In some reports WE appeared to be superior to both WI and air insufflation colonoscopy (AI) in terms of pain reduction and adenoma detection, particularly for <10 mm adenomas in the proximal colon.
In this multicenter, double-blinded randomized controlled trial (RCT) we test the hypothesis that that WE, compared to AI and WI, will enhance overall Adenoma Detection Rate (ADR) in CRC screening patients. Confirmation of the primary hypothesis will provide evidence that WE enhances the quality of screening colonoscopy.
We also hypothesize that WE may be more effective in detecting proximal colon adenomas than WI and AI, particularly <10 mm adenomas, thus increasing proximal colon ADR and proximal colon ADR <10 mm. Confirmation of secondary hypotheses will provide justification for further testing that WE may provide a strategy to improve prevention of colorectal cancer by increasing detection of adenomas in screening colonoscopy.
Unlike previous reports of single colonoscopist studies, the insertion and withdrawal phases of colonoscopy will be done by different investigators. The second investigator will be blinded to the method used to insert the instrument, thus eliminating possible bias about procedure related issues.
Several secondary outcomes will also be analysed.
Detailed description
Design: Prospective double-blinded multicenter randomized controlled trial. Methods: Colonoscopy with Air Insufflation, Water Immersion, Water Exchange to aid insertion of colonoscope; split dose bowel preparation. Sedation available at the start of the procedure or on-demand.
Control method: Air insufflation colonoscopy. Study methods: Water Immersion colonoscopy, Water Exchange colonoscopy.
Population: Consecutive 50 to 70 year-old screening patients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.
Primary outcome: overall Adenoma Detection Rate. Secondary outcomes: proximal colon ADR, Mean Adenomas resected per Procedure (MAP), cecal intubation rate and time, total procedure time (including biopsy and/or polypectomy), maximum pain during colonoscopy assessed during insertion and at discharge, the need for sedation/analgesia and its dosage. In addition loop reduction maneuvers, position changes, abdominal compression, the amount of infused and suctioned water during insertion and withdrawal, and patients willingness to repeat the examination will be evaluated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Air insufflation method. | Active comparator | Other: Air insufflation method.Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure. |
| Water Immersion method. | Experimental | Other: Water Immersion method.Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Withdrawal phase done using air insufflation. |
| Water Exchange method. | Experimental | Other: Water Exchange method.Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using air insufflation. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive screening patients
Key exclusion criteria (7 listed)
- previous colonoscopy within 5 years
- surveillance colonoscopy
- previous colorectal surgery
- indication for a proctosigmoidoscopy or bidirectional endoscopy
- history of inflammatory bowel disease
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 |
|---|---|---|
| Air insufflation method.Air insufflation colonoscopy. | Other | Air insufflation method. |
| Water Immersion method.Water Immersion during insertion, air insufflation during withdrawal. | Other | Water Immersion method. |
| Water Exchange method.Water Exchange during insertion, air insufflation during withdrawal. | Other | Water Exchange method. |
Primary outcome
Adenoma Detection Rate.
Time frame: 18 months.
Proportion of subjects with at least one adenoma of any size.
9 secondary outcomes
Proximal colon Adenoma Detection Rate.
Time frame: 18 months.
Proximal colon <10 mm Adenoma Detection Rate.
Time frame: 18 months.
Mean adenomas resected per procedure.
Time frame: 18 months.
Cecal intubation rate.
Time frame: 1 hour.
Cecal intubation time.
Time frame: 1 hour.
Total procedure time.
Time frame: 1 hour.
Maximum pain score recorded during insertion phase of colonoscopy.
Time frame: 1 hour.
Pain score at discharge.
Time frame: 1 hour.
Need for sedation/analgesia and its dosage
Time frame: 1 hour.
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 13 Apr 2016.
- Background: PubMed 22898423Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
- Background: PubMed 22835574Gupta S, Balasubramanian BA, Fu T, Genta RM, Rockey DC, Lash R. Polyps with advanced neoplasia are smaller in the right than in the left colon: implications for colorectal cancer screening. Clin Gastroenterol Hepatol. 2012 Dec;10(12):1395-1401.e2. doi: 10.1016/j.cgh.2012.07.004. Epub 2012 Jul 24.
- Background: PubMed 24218307Cadoni S, Gallittu P, Sanna S, Fanari V, Porcedda ML, Erriu M, Leung FW. A two-center randomized controlled trial of water-aided colonoscopy versus air insufflation colonoscopy. Endoscopy. 2014 Mar;46(3):212-8. doi: 10.1055/s-0033-1353604. Epub 2013 Nov 11.
- Background: PubMed 20883846Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
- Background: PubMed 23931857Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.
- Background: PubMed 22987214Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.
- Derived from this study: PubMed 28282689Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.
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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.
Sergio Cadoni, MD principal investigator
S. Barbara Hospital, Iglesias (CI), Italy
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air insufflation method., Water Immersion method. and Water Exchange method. in people with Colorectal Cancer and Colorectal Adenomas, run by Presidio Ospedaliero Santa Barbara at 4 sites in 3 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 1 inclusion and 7 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 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, United States, 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?
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?
Adenoma Detection Rate. (time frame: 18 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 NCT02041507, which also lists 7 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 13 Apr 2016.