Colonic PolypNCT04093557
Improving Outpatient Colonoscopy Bowel Prep With the Orton Score
A study testing Orton Score in people with Colonic Polyp and Colon Cancer, run by University of Virginia at 1 site in United States.
Trial summary
Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology \& Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colon Cancer
- What is being tested?
- Orton Score
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 6 Dec 2024
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older (up to 100 years)
- Referred for open access colonoscopy from an outside provider/UVA provider
- Able to provide informed consent
Who cannot join
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Medical Center
Charlottesville, Virginia, 22908
About this study
Official title: Validation of a Novel Clinical Prediction Scoring System for Improved Bowel Preparation Prior to Outpatient Colonoscopy
Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology \& Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. As a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. However, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals.
Given that the patient population described above are often not well-known to UVA providers, they may be prescribed prep regimens that are not ideal for their comorbidities. Not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection.
The investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. Because obtaining written consent is not practical given that these patients may not be seen by a UVA provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. Subjects be prescribed either a standard split-dose GoLytely prep (or SuPrep) or an extended split-dose GoLytely prep. The investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. The investigators will work with a UVA biostatistician to analyze the data and use Chi Square, student's T tests, and logistic regression models to assess significance and help validate the model.
- Conditions
- Colonic Polyp, Colon Cancer
- Being tested
- Orton Score, Typical Standard of Care
- Keywords
- colonoscopy, bowel prep, screening
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orton ScoreOther
Significant a priori predictors of poor prep included: male gender, COPD, diabetes with end-organ damage, severe neurologic disease, constipation medication use, and tricyclic antidepressant use. Proprietary web-based weighted scoring model allows screening clinician to predict which bowel prep would be best for patient depending on which risk factors patients have.
Typical Standard of CareOther
Clinician usual practice of prescribing bowel preps to patient
| Study group | Role | What they receive |
|---|---|---|
| Orton Score Cohort - High | Active comparator | Patients will be scored using the "Orton Score," a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they score highly, they will receive an extended GoLytely bowel prep. Receives: Other: Orton Score |
| Prospective Orton Score Cohort - Low | Placebo comparator | Patients will be scored using the "Orton Score," a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they do not score highly, they will receive a standard GoLytely (or Suprep) bowel prep. Receives: Other: Orton Score |
| Retrospective Cohort (before Orton Score) | Other | Not described Receives: Other: Typical Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate prep rate
Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance)
Measured: Through study duration, approximately 1 year
Secondary outcomes (4)
Adenoma detection rate (ADR)
Percentage of colonoscopies with detection of at least 1 adenoma
Measured: Through study duration, approximately 1 year
Polyp burden
Mean # of polyps found per colonoscopy
Measured: Through study duration, approximately 1 year
Advanced adenoma / adenocarcinoma detection rate
Percentage of colonoscopies with detection of an adenoma with high-grade dysplasia, tubulovillous adenoma, or adenocarcinoma
Measured: Through study duration, approximately 1 year
Incomplete colonoscopy rate
Percentage of colonoscopies that are unable to be completed secondary to inadequate prep or technical difficulty
Measured: Through study duration, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start6 Dec 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Why it stopped: Not enough funding for research coordinator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be assessed for the most appropriate bowel preparation prior to colonoscopy (standard vs. extended) based on a novel scoring tool that accounts for various clinical conditions.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Powell, MD, University of Virginia
- Investigators
- Steven M Powell, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093557
- Sponsor's protocol ID
- 21825
- Status last verified
- May 2023
- First submitted
- 13 Sep 2019
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
PubMed 25239068Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
PubMed 15758907Sherer EA, Imler TD, Imperiale TF. The effect of colonoscopy preparation quality on adenoma detection rates. Gastrointest Endosc. 2012 Mar;75(3):545-53. doi: 10.1016/j.gie.2011.09.022. Epub 2011 Dec 3.
PubMed 22138085Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
PubMed 21481857Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28.
PubMed 22381531Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
PubMed 12135020Khan MA, Piotrowski Z, Brown MD. Patient acceptance, convenience, and efficacy of single-dose versus split-dose colonoscopy bowel preparation. J Clin Gastroenterol. 2010 Apr;44(4):310-1. doi: 10.1097/MCG.0b013e3181c2c92a. No abstract available.
PubMed 19935082Marmo R, Rotondano G, Riccio G, Marone A, Bianco MA, Stroppa I, Caruso A, Pandolfo N, Sansone S, Gregorio E, D'Alvano G, Procaccio N, Capo P, Marmo C, Cipolletta L. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions. Gastrointest Endosc. 2010 Aug;72(2):313-20. doi: 10.1016/j.gie.2010.02.048. Epub 2010 Jun 19.
PubMed 20561621Eun CS, Han DS, Hyun YS, Bae JH, Park HS, Kim TY, Jeon YC, Sohn JH. The timing of bowel preparation is more important than the timing of colonoscopy in determining the quality of bowel cleansing. Dig Dis Sci. 2011 Feb;56(2):539-44. doi: 10.1007/s10620-010-1457-1. Epub 2010 Nov 2.
PubMed 21042853Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.
PubMed 19251013Ben-Horin S, Bar-Meir S, Avidan B. The outcome of a second preparation for colonoscopy after preparation failure in the first procedure. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):626-30. doi: 10.1016/j.gie.2008.08.027.
PubMed 19251002Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
PubMed 28291237ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.
PubMed 25595062Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442.
PubMed 18978506Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):819-826. doi: 10.1097/MEG.0000000000001175.
PubMed 29847488
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Clinical Prediction Scoring System for Improved Bowel Preparation Prior to Outpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT04093557
- Acronym / sponsor ID
- 21825
- Conditions
- Colonic Polyp, Colon Cancer
- Keywords
- colonoscopy, bowel prep, screening
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough funding for research coordinator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 18 Sep 2019 (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.
Colonoscopy is a common endoscopic procedure which the UVA Gastroenterology \& Hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. As a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. However, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals.
Given that the patient population described above are often not well-known to UVA providers, they may be prescribed prep regimens that are not ideal for their comorbidities. Not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection.
The investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. Because obtaining written consent is not practical given that these patients may not be seen by a UVA provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. Subjects be prescribed either a standard split-dose GoLytely prep (or SuPrep) or an extended split-dose GoLytely prep. The investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. The investigators will work with a UVA biostatistician to analyze the data and use Chi Square, student's T tests, and logistic regression models to assess significance and help validate the model.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All patients will be assessed for the most appropriate bowel preparation prior to colonoscopy (standard vs. extended) based on a novel scoring tool that accounts for various clinical conditions.
| Arm | Type | Receives |
|---|---|---|
| Orton Score Cohort - High | Active comparator | Other: Orton ScorePatients will be scored using the "Orton Score," a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they score highly, they will receive an extended GoLytely bowel prep. |
| Prospective Orton Score Cohort - Low | Placebo comparator | Other: Orton ScorePatients will be scored using the "Orton Score," a novel clinical prediction tool to determine which patients are at risk for poor bowel preps and may benefit from an extended prep. If they do not score highly, they will receive a standard GoLytely (or Suprep) bowel prep. |
| Retrospective Cohort (before Orton Score) | Other | Other: Typical Standard of Care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older (up to 100 years)
- Referred for open access colonoscopy from an outside provider/UVA provider
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Prisoners
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 |
|---|---|---|
| Orton ScoreSignificant a priori predictors of poor prep included: male gender, COPD, diabetes with end-organ damage, severe neurologic disease, constipation medication use, and tricyclic antidepressant use. Proprietary web-based weighted scoring model allows screening clinician to predict which bowel prep would be best for patient depending on which risk factors patients have. | Other | Orton Score Cohort - High, Prospective Orton Score Cohort - Low |
| Typical Standard of CareClinician usual practice of prescribing bowel preps to patient | Other | Retrospective Cohort (before Orton Score) |
Primary outcome
Inadequate prep rate
Time frame: Through study duration, approximately 1 year
Percentage of colonoscopies where performing endoscopist rates the prep as inadequate for intended purpose (screening/surveillance)
4 secondary outcomes
Adenoma detection rate (ADR)
Time frame: Through study duration, approximately 1 year
Polyp burden
Time frame: Through study duration, approximately 1 year
Advanced adenoma / adenocarcinoma detection rate
Time frame: Through study duration, approximately 1 year
Incomplete colonoscopy rate
Time frame: Through study duration, approximately 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Results publication: PubMed 25239068Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
- Results publication: PubMed 15758907Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
- Results publication: PubMed 22138085Sherer EA, Imler TD, Imperiale TF. The effect of colonoscopy preparation quality on adenoma detection rates. Gastrointest Endosc. 2012 Mar;75(3):545-53. doi: 10.1016/j.gie.2011.09.022. Epub 2011 Dec 3.
- Results publication: PubMed 21481857Lebwohl B, Kastrinos F, Glick M, Rosenbaum AJ, Wang T, Neugut AI. The impact of suboptimal bowel preparation on adenoma miss rates and the factors associated with early repeat colonoscopy. Gastrointest Endosc. 2011 Jun;73(6):1207-14. doi: 10.1016/j.gie.2011.01.051. Epub 2011 Apr 8.
- Results publication: PubMed 22381531Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28.
- Results publication: PubMed 12135020Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
- Results publication: PubMed 19935082Khan MA, Piotrowski Z, Brown MD. Patient acceptance, convenience, and efficacy of single-dose versus split-dose colonoscopy bowel preparation. J Clin Gastroenterol. 2010 Apr;44(4):310-1. doi: 10.1097/MCG.0b013e3181c2c92a. No abstract available.
- Results publication: PubMed 20561621Marmo R, Rotondano G, Riccio G, Marone A, Bianco MA, Stroppa I, Caruso A, Pandolfo N, Sansone S, Gregorio E, D'Alvano G, Procaccio N, Capo P, Marmo C, Cipolletta L. Effective bowel cleansing before colonoscopy: a randomized study of split-dosage versus non-split dosage regimens of high-volume versus low-volume polyethylene glycol solutions. Gastrointest Endosc. 2010 Aug;72(2):313-20. doi: 10.1016/j.gie.2010.02.048. Epub 2010 Jun 19.
- Results publication: PubMed 21042853Eun CS, Han DS, Hyun YS, Bae JH, Park HS, Kim TY, Jeon YC, Sohn JH. The timing of bowel preparation is more important than the timing of colonoscopy in determining the quality of bowel cleansing. Dig Dis Sci. 2011 Feb;56(2):539-44. doi: 10.1007/s10620-010-1457-1. Epub 2010 Nov 2.
- Results publication: PubMed 19251013Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.
- Results publication: PubMed 19251002Ben-Horin S, Bar-Meir S, Avidan B. The outcome of a second preparation for colonoscopy after preparation failure in the first procedure. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):626-30. doi: 10.1016/j.gie.2008.08.027.
- Results publication: PubMed 28291237Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
- 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.
Steven M Powell, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orton Score in people with Colonic Polyp and Colon Cancer, run by University of Virginia at 1 site 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 12 Dec 2024. 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 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Inadequate prep rate (time frame: Through study duration, approximately 1 year). 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 NCT04093557, which also lists 16 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 2024.