Unsedated ColonoscopyNCT03160859
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
A study testing Study method in people with Unsedated Colonoscopy and Water Exchange Colonoscopy, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Unsedated Colonoscopy, Water Exchange Colonoscopy, Cap
- What is being tested?
- Study method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jun 2018to 28 Oct 2022
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
- diagnostic
- surveillance (follow up of polyps)
- screening (first-time) colonoscopy at participating sites
- choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)
Who cannot join
- decline to be randomized
- unable to give consent or respond to questionnaires
- history of colon surgery
- active inflammatory bowel disease
- lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
- therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
Show all 31Show fewer
- proctosigmoidoscopy
- bidirectional endoscopy
- inadequate consumption of bowel preparation
- known history of severe diverticulosis or diverticulitis
- history of abdominal surgery previously requiring sedation for colonoscopy
- current narcotic/anxiolytic medication use
- prior unsuccessful experience with unsedated colonoscopy
- emergent colonoscopy
- evidence of colonic obstruction based on pre-colonoscopy clinical evaluation
- current participation in other studies
- medical condition that could increase the risk associated with colonoscopy
- active cardiac
- or pulmonary disease
- or other serious disease
- medical condition that would preclude a benefit from colonoscopic screening
- cancer
- or any terminal illness
- prosthetic heart valve
- anticoagulant therapy
- nonmedical problems
- psychiatric disorders
- excessive use of alcohol
- need for special precautions in performing colonoscopy
- antibiotic prophylaxis
- request of on demand sedation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, 91343
About this study
Official title: Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). 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 during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
Read the detailed description
This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) 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 arms (WE, WE + cap) to see which one is less painful.
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 type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.
Control Method: One arm of the study will include unsedated colonoscopy with water exchange (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 arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.
- Being tested
- Control, Study method
- Keywords
- unsedated colonoscopy, water exchange colonoscopy, cap, colonoscopy pain
- Medical subject headings
- Anterior polar cataract 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Water exchange method
Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
Study methodDevice
Also called Water exchange method plus cap
Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
| Study group | Role | What they receive |
|---|---|---|
| Control Method | Other | One arm of the study will include unsedated colonoscopy with water exchange (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 predominantly during insertion. Receives: Other: Control |
| Study Method | Other | The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. 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 predominantly during insertion. Receives: Device: Study method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real Time Maximum Insertion Pain
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
Measured: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Secondary outcomes (3)
Proportion of Patients With No Insertion Pain
Proportion of patients who report no pain during insertion of the colonoscope.
Measured: Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Insertion Time
Time to cecum (clock display on monitor), faster insertion is a quality marker
Measured: Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Right Colon Adenoma Detection Rate (ADR)
Right colon Adenoma Detection Rate (ADR) is the proportion of patients with at least one adenoma in the part of the colon between the cecum and the hepatic flexure.
Measured: Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start8 Jun 2018
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
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 (26)Papers the sponsor has linked to this study.
- Other trials for Unsedated ColonoscopyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. 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. Control Method: Involves unsedated colonoscopy with water exchange. Residual air 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: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Northern California Health Care System, VA Palo Alto Health Care System
- Responsible party
- Sponsor
- Investigators
- Felix W. Leung, MD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160859
- Sponsor's protocol ID
- GAST-015-16S
- Status last verified
- Nov 2023
- First submitted
- 12 May 2017
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wolff WI, Shinya H. Polypectomy via the fiberoptic colonoscope. Removal of neoplasms beyond reach of the sigmoidoscope. N Engl J Med. 1973 Feb 15;288(7):329-32. doi: 10.1056/NEJM197302152880701. No abstract available.
PubMed 4682941Leung FW. The case of unsedated screening colonoscopy in the United States. Gastrointest Endosc. 2009 Jun;69(7):1354-6. doi: 10.1016/j.gie.2008.12.234. Epub 2009 Feb 27. No abstract available.
PubMed 19249764Leung FW, Aljebreen AM, Brocchi E, Chang EB, Liao WC, Mizukami T, Schapiro M, Triantafyllou K. Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening. World J Gastrointest Endosc. 2010 Mar 16;2(3):81-9. doi: 10.4253/wjge.v2.i3.81.
PubMed 21160707Leung FW. Is there a place for sedationless colonoscopy? J Interv Gastroenterol. 2011 Jan;1(1):19-22. doi: 10.4161/jig.1.1.14592.
PubMed 21686108Cataldo PA. Colonoscopy without sedation. Dis Colon Rectum. 1996 Mar;39(3):257-61. doi: 10.1007/BF02049463.
PubMed 8603544Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol. 1998 Jun;26(4):279-82. doi: 10.1097/00004836-199806000-00013.
PubMed 9649011Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999 May;49(5):554-9. doi: 10.1016/s0016-5107(99)70381-0.
PubMed 10228251Subramanian S, Liangpunsakul S, Rex DK. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol. 2005 Jul;39(6):516-9. doi: 10.1097/01.mcg.0000165667.79530.44.
PubMed 15942439Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol. 1999 Jul;94(7):1862-5. doi: 10.1111/j.1572-0241.1999.01219.x.
PubMed 10406249Leung FW. Patients' perspective - written testimonials from physician-patients and oral accounts presented by patients in person. J Interv Gastroenterol. 2011 Jan;1(1):45-46. doi: 10.4161/jig.1.1.14605. No abstract available.
PubMed 21686115Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29.
PubMed 17608779Leung FW. Unsedated colonoscopy introduced to ensure access is acceptable to a subgroup of veterans. Dig Dis Sci. 2008 Oct;53(10):2719-22. doi: 10.1007/s10620-007-0192-8. Epub 2008 Feb 15.
PubMed 18274901Felix W. Leung, Hartley Cohen, Stanley K. Dea, Dennis M. Jensen, Thomas O. Kovacs, Gordon V. Ohning, Joseph R. Pisegna, Alireza Sedarat, Alan Sheinbaum, Timothy C. Simmons, Rebecca Slomovic, Brennan M. Spiegel, Mitchell J. Spirt, James Sul and Rabindra R. Watson. Scheduled unsedated colonoscopy - a novel tool for managing no shows due to lack of escorts required for conscious sedation. Gastrointestinal Endoscopy, 2014-05-01, Volume 79, Issue 5, Pages AB178-AB179
Terruzzi V, Meucci G, Radaelli F, Terreni N, Minoli G. Routine versus "on demand" sedation and analgesia for colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2001 Aug;54(2):169-74. doi: 10.1067/mge.2001.113923.
PubMed 11474385Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.
PubMed 20619405
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
- ClinicalTrials.gov ID
- NCT03160859
- Acronym / sponsor ID
- GAST-015-16S
- Keywords
- unsedated colonoscopy, water exchange colonoscopy, cap, colonoscopy pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Northern California Health Care System, VA Palo Alto Health Care System
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 12 Dec 2023
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 undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). 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 during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
Detailed description
This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) 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 arms (WE, WE + cap) to see which one is less painful.
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 type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.
Control Method: One arm of the study will include unsedated colonoscopy with water exchange (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 arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a multi-VA site, prospective RCT to compare different methods with 2 arms to determine which is less painful: water alone or water plus cap. Randomization will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. 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. Control Method: Involves unsedated colonoscopy with water exchange. Residual air 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: Involves unsedated colonoscopy with water exchange and the addition of a commercially available accessory fitted onto the colonoscope.
| Arm | Type | Receives |
|---|---|---|
| Control Method | Other | Other: ControlOne arm of the study will include unsedated colonoscopy with water exchange (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 predominantly during insertion. |
| Study Method | Other | Device: Study methodThe other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a simple commercially available accessory to the colonoscopy device: a cap (Disposable Distal Attachment, Olympus Medical Systems Corp., Tokyo, Japan) fitted to the colonoscope per manufacturer instruction. 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 predominantly during insertion. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
Key exclusion criteria (31 listed)
- decline to be randomized
- unable to give consent or respond to questionnaires
- history of colon surgery
- active inflammatory bowel disease
- lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
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 |
|---|---|---|
| ControlAlso: Water exchange methodUnsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion. | Other | Control Method |
| Study methodAlso: Water exchange method plus capUnsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope. | Device | Study Method |
Primary outcome
Real Time Maximum Insertion Pain
Time frame: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
3 secondary outcomes
Proportion of Patients With No Insertion Pain
Time frame: Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Insertion Time
Time frame: Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Right Colon Adenoma Detection Rate (ADR)
Time frame: Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4682941Wolff WI, Shinya H. Polypectomy via the fiberoptic colonoscope. Removal of neoplasms beyond reach of the sigmoidoscope. N Engl J Med. 1973 Feb 15;288(7):329-32. doi: 10.1056/NEJM197302152880701. No abstract available.
- Background: PubMed 19249764Leung FW. The case of unsedated screening colonoscopy in the United States. Gastrointest Endosc. 2009 Jun;69(7):1354-6. doi: 10.1016/j.gie.2008.12.234. Epub 2009 Feb 27. No abstract available.
- Background: PubMed 21160707Leung FW, Aljebreen AM, Brocchi E, Chang EB, Liao WC, Mizukami T, Schapiro M, Triantafyllou K. Sedation-risk-free colonoscopy for minimizing the burden of colorectal cancer screening. World J Gastrointest Endosc. 2010 Mar 16;2(3):81-9. doi: 10.4253/wjge.v2.i3.81.
- Background: PubMed 21686108Leung FW. Is there a place for sedationless colonoscopy? J Interv Gastroenterol. 2011 Jan;1(1):19-22. doi: 10.4161/jig.1.1.14592.
- Background: PubMed 8603544Cataldo PA. Colonoscopy without sedation. Dis Colon Rectum. 1996 Mar;39(3):257-61. doi: 10.1007/BF02049463.
- Background: PubMed 9649011Hoffman MS, Butler TW, Shaver T. Colonoscopy without sedation. J Clin Gastroenterol. 1998 Jun;26(4):279-82. doi: 10.1097/00004836-199806000-00013.
- Background: PubMed 10228251Rex DK, Imperiale TF, Portish V. Patients willing to try colonoscopy without sedation: associated clinical factors and results of a randomized controlled trial. Gastrointest Endosc. 1999 May;49(5):554-9. doi: 10.1016/s0016-5107(99)70381-0.
- Background: PubMed 15942439Subramanian S, Liangpunsakul S, Rex DK. Preprocedure patient values regarding sedation for colonoscopy. J Clin Gastroenterol. 2005 Jul;39(6):516-9. doi: 10.1097/01.mcg.0000165667.79530.44.
- Background: PubMed 10406249Early DS, Saifuddin T, Johnson JC, King PD, Marshall JB. Patient attitudes toward undergoing colonoscopy without sedation. Am J Gastroenterol. 1999 Jul;94(7):1862-5. doi: 10.1111/j.1572-0241.1999.01219.x.
- Background: PubMed 21686115Leung FW. Patients' perspective - written testimonials from physician-patients and oral accounts presented by patients in person. J Interv Gastroenterol. 2011 Jan;1(1):45-46. doi: 10.4161/jig.1.1.14605. No abstract available.
- Background: PubMed 17608779Jonas DE, Russell LB, Sandler RS, Chou J, Pignone M. Patient time requirements for screening colonoscopy. Am J Gastroenterol. 2007 Nov;102(11):2401-10. doi: 10.1111/j.1572-0241.2007.01387.x. Epub 2007 Jun 29.
- Background: PubMed 18274901Leung FW. Unsedated colonoscopy introduced to ensure access is acceptable to a subgroup of veterans. Dig Dis Sci. 2008 Oct;53(10):2719-22. doi: 10.1007/s10620-007-0192-8. Epub 2008 Feb 15.
- Individual participant dataSharing planned: No
Related trials for Unsedated Colonoscopy
Not yet recruiting
Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy
Colonoscopy Pain
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, Sepulveda, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study method in people with Unsedated Colonoscopy and Water Exchange Colonoscopy, run by VA Office of Research and Development at 3 sites in United States.
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 5 inclusion and 31 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 12 Dec 2023). 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?
Real Time Maximum Insertion Pain (time frame: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour). 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 NCT03160859, which also lists 26 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 12 Dec 2023.