Right Colon Adenoma Miss RateNCT04124393
Multicenter Evaluation of Right Colon Polyp Miss Rates Using Water Exchange Versus CO2 Insufflation
A study testing Colon Polypectomy in people with Right Colon Adenoma Miss Rate and Right Colon Hyperplastic Polyp Miss Rate, run by Evergreen General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
A prospective multicenter randomized controlled trial (RCT) comparing water exchange (WE) colonoscopy and carbon dioxide (CO2) insufflation in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Right Colon Adenoma Miss Rate, Right Colon Hyperplastic Polyp Miss Rate
- What is being tested?
- Colon Polypectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2019to 31 Dec 2022
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive fecal immunochemical test will be considered for enrollment.
Who cannot join
- Familial adenomatous polyposis and hereditary non-polyposis colorectal cancer (CRC) syndrome, personal history of CRC or inflammatory bowel disease, previous colonic resection, obstructive lesions of the colon, gastrointestinal bleeding, allergy to fentanyl, midazolam or propofol, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Right Colon Adenoma and Hyperplastic Polyp Miss Rates in Colonoscopy Using Water Exchange and CO2 Insufflation: A Multicenter Randomized Tandem Study
A prospective multicenter randomized controlled trial (RCT) comparing water exchange (WE) colonoscopy and carbon dioxide (CO2) insufflation in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection.
Read the detailed description
This will be a prospective RCT comparing CO2 insufflation and WE in terms of right colon combined AMR and HPMR by tandem inspection. It will be a multicenter study conducted in three community hospitals (Evergreen General Hospital, Taoyuan; Dalin Tzu-Chi Hospital, Chiayi; Taipei Medical University Hospital, Taipei) in Taiwan. Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment from December 2019 to May 2021. A written informed consent will be obtained from all participating patients. Participants will be randomized in a 1:1 ratio to undergo either the CO2 insufflation colonoscopy (CO2 group) or WE colonoscopy (WE group). WE colonoscopies will be performed by five board-certified colonoscopists (Chi-Liang Cheng, Yen-Lin Kuo [Evergreen General Hospital]; Yu-Hsi Hsieh, Chih-Wei Tseng [Dalin Tzu-Chi Hospital]; Jui-Hsiang Tang [Taipei Medical University Hospital]. Standard colonoscopes (CF-Q260AL/I, CF-HQ290L/I; Olympus Medical Systems Corp., Tokyo, Japan) will be used. Felix W. Leung will be involved in the study design, data analyses, and report preparation, but not in patient enrollment. Antispasmodic medication will not be administered during colonoscopy examination. CO2 insufflation will be used for CO2 group and the withdrawal phase of the WE group. In the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, air and residual water or feces in the rectum will be aspirated, and then the colon will be irrigated with warm water. When the cecum is reached and after most of the water is suctioned to collapse the cecal lumen, CO2 will be opened. In the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used in both groups and the scope will be withdrawn from the cecum to the hepatic flexure, with inspection of the mucosa at the same time. All polyps identified will be resected and sent for pathology evaluation. The most distal part of the hepatic flexure will be marked by a forceps biopsy and then the scope will be reinserted into the cecum by the first endoscopist using CO2 insufflation. A tandem inspection of the right colon will then be performed by a blinded endoscopist in both study groups. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed.
- Being tested
- Colon Polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon PolypectomyProcedure or surgery
Polyp search and resection will be performed entirely during the withdrawal phase in both WE and CO2 groups. Insertion inspection and polypectomy will not be performed. All polyps in the proximal colon, defined as cecum, ascending colon, hepatic flexure, and transverse colon, will be removed irrespective of their size and appearance.
| Study group | Role | What they receive |
|---|---|---|
| Water Exchange (WE) Colonoscopy | Active comparator | In the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, the colon will be irrigated with warm water (32C-35C). WE entails the infusion of water to open the lumen and simultaneous suction if the endoscope has two channels, and sequentially if the endoscope has only one channel. When the cecum is reached and after most of the water is suctioned to collapse the cecal lumen, CO2 will be opened. The colonoscope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The colonoscope will then be reinserted into the cecum by the first endoscopist. A tandem inspection of the right colon will be performed by a blinded endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Receives: Procedure: Colon Polypectomy |
| CO2 Insufflation Colonoscopy | Active comparator | In the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the colonoscope will be withdrawn from the cecum to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then, the colonoscope will be reinserted into the cecum by the first endoscopist. A tandem inspection of the right colon will be performed by a blinded endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Receives: Procedure: Colon Polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Colon Adenoma Miss Rate
Lesions detected on the tandem right colon examination will be used for the calculation of adenoma miss rate. Right colon adenooma miss rate will be calculated as the the number of adenomas missed during the first right colon examination divided by the total number of adenomas detected during both the first and tandem right colon examinations.
Measured: One day
Right Colon Hyperplastic Polyp Miss Rate
Lesions detected on the tandem right colon examination will be used for the calculation of hyperplastic polyp miss rate. Right colon hyperplastic polyp miss rate will be calculated as the the number of hyperplastic polyps missed during the first right colon examination divided by the total number of hyperplalstic polyps detected during both the first and tandem right colon examinations.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Dec 2019
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Right Colon Adenoma Miss RateStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, Dalin Tzu Chi General Hospital, Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
- Responsible party
- Sponsor
- Investigators
- Chiliang Cheng, M.D., Principal investigator, Evergreen General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124393
- Sponsor's protocol ID
- EGH-2020
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2019
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
PubMed 23744612Fuccio L, Frazzoni L, Hassan C, La Marca M, Paci V, Smania V, De Bortoli N, Bazzoli F, Repici A, Rex D, Cadoni S. Water exchange colonoscopy increases adenoma detection rate: a systematic review with network meta-analysis of randomized controlled studies. Gastrointest Endosc. 2018 Oct;88(4):589-597.e11. doi: 10.1016/j.gie.2018.06.028. Epub 2018 Jul 5.
PubMed 29981753Leung FW, Koo M, Cadoni S, Falt P, Hsieh YH, Amato A, Erriu M, Fojtik P, Gallittu P, Hu CT, Leung JW, Liggi M, Paggi S, Radaelli F, Rondonotti E, Smajstrla V, Tseng CW, Urban O. Water Exchange Produces Significantly Higher Adenoma Detection Rate Than Water Immersion: Pooled Data From 2 Multisite Randomized Controlled Trials. J Clin Gastroenterol. 2019 Mar;53(3):204-209. doi: 10.1097/MCG.0000000000001012.
PubMed 29505552Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Water exchange colonoscopy decreased adenoma miss rates compared with literature data and local data with CO2 insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2.
PubMed 31412789Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
PubMed 30738046Cheng CL, Tang JH, Hsieh YH, Kuo YL, Fang KC, Tseng CW, Su IC, Chang CC, Tsui YN, Lee BP, Zou KY, Lee YS, Leung FW. Comparing Right-Sided Colon Adenoma and Serrated Polyp Miss Rates With Water Exchange and CO 2 Insufflation: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Oct 30;120(7):1615-1623. doi: 10.14309/ajg.0000000000003168.
PubMed 39471473
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Right Colon Adenoma and Hyperplastic Polyp Miss Rates in Colonoscopy Using Water Exchange and CO2 Insufflation: A Multicenter Randomized Tandem Study
- ClinicalTrials.gov ID
- NCT04124393
- Acronym / sponsor ID
- EGH-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, Dalin Tzu Chi General Hospital, Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Oct 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.
A prospective multicenter randomized controlled trial (RCT) comparing water exchange (WE) colonoscopy and carbon dioxide (CO2) insufflation in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection.
Detailed description
This will be a prospective RCT comparing CO2 insufflation and WE in terms of right colon combined AMR and HPMR by tandem inspection. It will be a multicenter study conducted in three community hospitals (Evergreen General Hospital, Taoyuan; Dalin Tzu-Chi Hospital, Chiayi; Taipei Medical University Hospital, Taipei) in Taiwan. Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment from December 2019 to May 2021. A written informed consent will be obtained from all participating patients. Participants will be randomized in a 1:1 ratio to undergo either the CO2 insufflation colonoscopy (CO2 group) or WE colonoscopy (WE group). WE colonoscopies will be performed by five board-certified colonoscopists (Chi-Liang Cheng, Yen-Lin Kuo [Evergreen General Hospital]; Yu-Hsi Hsieh, Chih-Wei Tseng [Dalin Tzu-Chi Hospital]; Jui-Hsiang Tang [Taipei Medical University Hospital]. Standard colonoscopes (CF-Q260AL/I, CF-HQ290L/I; Olympus Medical Systems Corp., Tokyo, Japan) will be used. Felix W. Leung will be involved in the study design, data analyses, and report preparation, but not in patient enrollment. Antispasmodic medication will not be administered during colonoscopy examination. CO2 insufflation will be used for CO2 group and the withdrawal phase of the WE group. In the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, air and residual water or feces in the rectum will be aspirated, and then the colon will be irrigated with warm water. When the cecum is reached and after most of the water is suctioned to collapse the cecal lumen, CO2 will be opened. In the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used in both groups and the scope will be withdrawn from the cecum to the hepatic flexure, with inspection of the mucosa at the same time. All polyps identified will be resected and sent for pathology evaluation. The most distal part of the hepatic flexure will be marked by a forceps biopsy and then the scope will be reinserted into the cecum by the first endoscopist using CO2 insufflation. A tandem inspection of the right colon will then be performed by a blinded endoscopist in both study groups. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Exchange (WE) Colonoscopy | Active comparator | Procedure: Colon PolypectomyIn the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, the colon will be irrigated with warm water (32C-35C). WE entails the infusion of water to open the lumen and simultaneous suction if the endoscope has two channels, and sequentially if the endoscope has only one channel. When the cecum is reached and after most of the water is suctioned to collapse the cecal lumen, CO2 will be opened. The colonoscope will be withdrawn to the hepatic flexure. All polyps identified will be resected (colon polypectomy). The colonoscope will then be reinserted into the cecum by the first endoscopist. A tandem inspection of the right colon will be performed by a blinded endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. |
| CO2 Insufflation Colonoscopy | Active comparator | Procedure: Colon PolypectomyIn the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used and the colonoscope will be withdrawn from the cecum to the hepatic flexure. All polyps identified will be resected (colon polypectomy). Then, the colonoscope will be reinserted into the cecum by the first endoscopist. A tandem inspection of the right colon will be performed by a blinded endoscopist. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive fecal immunochemical test will be considered for enrollment.
Key exclusion criteria (1 listed)
- Familial adenomatous polyposis and hereditary non-polyposis colorectal cancer (CRC) syndrome, personal history of CRC or inflammatory bowel disease, previous colonic resection, obstructive lesions of the colon, gastrointestinal bleeding, allergy to fentanyl, midazolam or propofol, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon PolypectomyPolyp search and resection will be performed entirely during the withdrawal phase in both WE and CO2 groups. Insertion inspection and polypectomy will not be performed. All polyps in the proximal colon, defined as cecum, ascending colon, hepatic flexure, and transverse colon, will be removed irrespective of their size and appearance. | Procedure or surgery | CO2 Insufflation Colonoscopy, Water Exchange (WE) Colonoscopy |
Primary outcome
Right Colon Adenoma Miss Rate
Time frame: One day
Lesions detected on the tandem right colon examination will be used for the calculation of adenoma miss rate. Right colon adenooma miss rate will be calculated as the the number of adenomas missed during the first right colon examination divided by the total number of adenomas detected during both the first and tandem right colon examinations.
Right Colon Hyperplastic Polyp Miss Rate
Time frame: One day
Lesions detected on the tandem right colon examination will be used for the calculation of hyperplastic polyp miss rate. Right colon hyperplastic polyp miss rate will be calculated as the the number of hyperplastic polyps missed during the first right colon examination divided by the total number of hyperplalstic polyps detected during both the first and tandem right colon examinations.
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 8 Dec 2023.
- Background: PubMed 23744612le Clercq CM, Bouwens MW, Rondagh EJ, Bakker CM, Keulen ET, de Ridder RJ, Winkens B, Masclee AA, Sanduleanu S. Postcolonoscopy colorectal cancers are preventable: a population-based study. Gut. 2014 Jun;63(6):957-63. doi: 10.1136/gutjnl-2013-304880. Epub 2013 Jun 6.
- Background: PubMed 29981753Fuccio L, Frazzoni L, Hassan C, La Marca M, Paci V, Smania V, De Bortoli N, Bazzoli F, Repici A, Rex D, Cadoni S. Water exchange colonoscopy increases adenoma detection rate: a systematic review with network meta-analysis of randomized controlled studies. Gastrointest Endosc. 2018 Oct;88(4):589-597.e11. doi: 10.1016/j.gie.2018.06.028. Epub 2018 Jul 5.
- Background: PubMed 29505552Leung FW, Koo M, Cadoni S, Falt P, Hsieh YH, Amato A, Erriu M, Fojtik P, Gallittu P, Hu CT, Leung JW, Liggi M, Paggi S, Radaelli F, Rondonotti E, Smajstrla V, Tseng CW, Urban O. Water Exchange Produces Significantly Higher Adenoma Detection Rate Than Water Immersion: Pooled Data From 2 Multisite Randomized Controlled Trials. J Clin Gastroenterol. 2019 Mar;53(3):204-209. doi: 10.1097/MCG.0000000000001012.
- Background: PubMed 31412789Cheng CL, Kuo YL, Hsieh YH, Tang JH, Leung FW. Water exchange colonoscopy decreased adenoma miss rates compared with literature data and local data with CO2 insufflation: an observational study. BMC Gastroenterol. 2019 Aug 14;19(1):143. doi: 10.1186/s12876-019-1065-2.
- Background: PubMed 30738046Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
- Derived from this study: PubMed 39471473Cheng CL, Tang JH, Hsieh YH, Kuo YL, Fang KC, Tseng CW, Su IC, Chang CC, Tsui YN, Lee BP, Zou KY, Lee YS, Leung FW. Comparing Right-Sided Colon Adenoma and Serrated Polyp Miss Rates With Water Exchange and CO 2 Insufflation: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Oct 30;120(7):1615-1623. doi: 10.14309/ajg.0000000000003168.
- Individual participant dataSharing planned: No
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.
Chiliang Cheng, M.D. principal investigator
Evergreen General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon Polypectomy in people with Right Colon Adenoma Miss Rate and Right Colon Hyperplastic Polyp Miss Rate, run by Evergreen General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 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: finished, as of the sponsor's last update on 8 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 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Colon Adenoma Miss Rate (time frame: One day). The study lists 2 primary outcomes in all. 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 NCT04124393, which also lists 6 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 8 Dec 2023.