ColonoscopyNCT07830823
Water Exchange Colonoscopy in Elderly Patients
A study testing Water exchange colonoscopy, Gas insufflation colonoscopy and Propofol and opioid anesthesia in people with Colonoscopy and Colorectal Cancer Screening, run by First People's Hospital Of Lin'an District, Hangzhou at 1 site in China.
Trial summary
Colonoscopy is an important test for detecting colorectal polyps and cancer, but it can cause pain and discomfort, especially in older adults. Traditional colonoscopy uses air to expand the colon. Water exchange colonoscopy uses warm water instead of air, which may reduce pain and make the examination easier. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Colonoscopy, Colorectal Cancer Screening
- What is being tested?
- Water exchange colonoscopy, Gas insufflation colonoscopy and Propofol and opioid anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Jan 2026
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 55 years
- Indications for colonoscopy
- Signed informed consent form
Who cannot join
- History of intestinal surgery
- Severe intestinal stenosis or obstruction
- Cognitive impairment that precludes cooperation with assessment
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou
Hangzhou, Zhejiang, 311300
About this study
Official title: Water Exchange Colonoscopy in Elderly Patients: A Prospective Randomized Controlled Trial
Colonoscopy is an important test for detecting colorectal polyps and cancer, but it can cause pain and discomfort, especially in older adults. Traditional colonoscopy uses air to expand the colon. Water exchange colonoscopy uses warm water instead of air, which may reduce pain and make the examination easier. This study compared four colonoscopy methods in patients aged 55 years and older: non-anesthesia water injection, non-anesthesia gas insufflation, anesthesia water injection, and anesthesia gas insufflation. Two hundred participants were randomly assigned to one of the four groups. The study measured pain using a visual analog scale, the time needed to reach the cecum, and blood levels of inflammatory markers (IL-1β, IL-6, and PGE2). The results may help doctors choose a safer and more comfortable colonoscopy method for older patients, especially when anesthesia may not be suitable.
Read the detailed description
Background: Colorectal cancer incidence and mortality increase with age, and colonoscopy is essential for screening and managing colorectal polyps. Conventional gas insufflation can cause abdominal distension, pain, and loop formation, particularly in elderly patients who often have relaxed abdominal muscles, elongated colons, and comorbidities that increase anesthesia risk. Water exchange colonoscopy has been reported to reduce pain by using warm water to navigate the colon without full gas distension.
Objective: To evaluate the clinical value of non-anesthesia water exchange colonoscopy in elderly patients and compare it with anesthesia water exchange, non-anesthesia gas insufflation, and anesthesia gas insufflation.
Methods: This was a single-center, prospective, randomized controlled trial that enrolled 200 patients aged 55 years or older undergoing colonoscopy between November 2024 and December 2025. Participants were randomly assigned (1:1:1:1) using a random number table to four groups (n=50 each): non-anesthesia water injection (NW), non-anesthesia gas insufflation (NA), anesthesia water injection (AW), and anesthesia gas insufflation (AA). All procedures were performed by an experienced endoscopist using a high-definition colonoscope (Olympus CF-HQ290I). Bowel preparation used standard polyethylene glycol electrolyte powder. In water injection groups, warm water at 37°C was injected through the biopsy channel during insertion, with suction of gas and fluid as needed. In gas insufflation groups, conventional air insufflation was used. Anesthesia groups received intravenous propofol combined with a small amount of opioid, administered by an anesthesiologist with continuous vital sign monitoring. The non-anesthesia groups received no anesthesia or analgesia.
Outcomes: The primary outcomes included maximum pain score during examination measured by a 10-point visual analog scale (VAS), cecal intubation time (minutes from insertion to identification of the ileocecal landmark), and serum levels of inflammatory and pain mediators (IL-1β, IL-6, and PGE2) measured by ELISA before and during colonoscopy. Non-inferiority of AW versus NW was assessed for inflammatory mediator inhibition using pre-specified margins. Statistical analysis used SPSS 25.0, with one-way ANOVA, Tukey HSD test, chi-square test, and non-inferiority testing; P<0.05 was considered statistically significant.
- Conditions
- Colonoscopy, Colorectal Cancer Screening
- Being tested
- Water exchange colonoscopy, Gas insufflation colonoscopy, Propofol and opioid anesthesia
- Keywords
- Water exchange colonoscopy, elderly patients, non-anesthesia, pain score, inflammatory mediators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water exchange colonoscopyProcedure or surgery
Also called Water-aided colonoscopy
During endoscope insertion, warm water at 37°C is injected through the biopsy channel to facilitate the procedure. Gas and liquid within the cavity are aspirated as thoroughly as possible. A minimal amount of gas is introduced for observation when necessary.
Gas insufflation colonoscopyProcedure or surgery
Also called Air insufflation colonoscopy
Conventional air insufflation is employed to expand the intestinal lumen, thereby aiding in endoscope insertion.
Propofol and opioid anesthesiaDrug
Also called Intravenous anesthesia
Intravenous general anesthesia consisting of propofol combined with a small quantity of opioid drugs, administered by an anesthesiologist prior to the examination, with continuous monitoring of vital signs.
| Study group | Role | What they receive |
|---|---|---|
| Non-anesthesia water injection (NW) | Experimental | Participants receive water exchange colonoscopy without anesthesia. Warm water at 37°C is injected through the biopsy channel during insertion; gas and fluid are aspirated as needed. No anesthesia or analgesia is administered. Receives: Procedure: Water exchange colonoscopy |
| Non-anesthesia gas insufflation (NA) | Experimental | Participants receive conventional gas insufflation colonoscopy without anesthesia. Air is used to expand the intestinal lumen. No anesthesia or analgesia is administered. Receives: Procedure: Gas insufflation colonoscopy |
| Anesthesia water injection (AW) | Experimental | Participants receive water exchange colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. Receives: Procedure: Water exchange colonoscopy; Drug: Propofol and opioid anesthesia |
| Anesthesia gas insufflation (AA) | Experimental | Participants receive conventional gas insufflation colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. Receives: Procedure: Gas insufflation colonoscopy; Drug: Propofol and opioid anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum inflammatory factors and pain mediators
Change from baseline in serum levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and prostaglandin E2 (PGE2) measured by ELISA before and during colonoscopy. Used for non-inferiority comparison between non-anesthesia water injection (NW) and anesthesia water injection (AW).
Measured: Baseline and periprocedural
Pain score (VAS)
Maximum pain level during colonoscopy assessed by the patient using a visual analog scale (VAS, 0-10 points, where 0 indicates no pain and 10 signifies severe pain).
Measured: Periprocedural
Secondary outcomes (2)
Cecal intubation time
Duration from colonoscope insertion to reaching the ileocecal area and identifying the cecal landmark (e.g., appendiceal orifice or ileocecal valve), recorded in minutes.
Measured: Periprocedural
Adverse events
Incidence of procedure-related adverse events, including abdominal distension, pain, intestinal perforation, respiratory depression, cardiovascular events, and allergic reactions.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Nov 2024
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of four parallel groups (1:1:1:1 ratio): non-anesthesia water injection (NW), non-anesthesia gas insufflation (NA), anesthesia water injection (AW), and anesthesia gas insufflation (AA).
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital Of Lin'an District, Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjian Liao, First People's Hospital Of Lin'an District, Hangzhou
- Investigators
- Yongjian Liao, MD, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830823
- Sponsor's protocol ID
- LY2024013K
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu X, Ni D, Lu Y, Huang X. Diagnostic application of water exchange colonoscopy: A meta-analysis of randomized controlled trials. J Int Med Res. 2019 Feb;47(2):515-527. doi: 10.1177/0300060518819626. Epub 2019 Jan 11.
PubMed 30632431Cadoni S, Ishaq S, Hassan C, Falt P, Fuccio L, Siau K, Leung JW, Anderson J, Binmoeller KF, Radaelli F, Rutter MD, Sugimoto S, Muhammad H, Bhandari P, Draganov PV, de Groen P, Wang AY, Yen AW, Hamerski C, Thorlacius H, Neumann H, Ramirez F, Mulder CJJ, Albeniz E, Amato A, Arai M, Bak A, Barret M, Bayupurnama P, Cheung R, Ching HL, Cohen H, Dolwani S, Friedland S, Harada H, Hsieh YH, Hayee B, Kuwai T, Lorenzo-Zuniga V, Liggi M, Mizukami T, Mura D, Nylander D, Olafsson S, Paggi S, Pan Y, Parra-Blanco A, Ransford R, Rodriguez-Sanchez J, Senturk H, Suzuki N, Tseng CW, Uchima H, Uedo N, Leung FW. Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations. Gastrointest Endosc. 2021 Jun;93(6):1411-1420.e18. doi: 10.1016/j.gie.2020.10.011. Epub 2020 Oct 16.
PubMed 33069706Ding Y, Lin X. Outcomes and safety of colonoscopy in elderly patients aged 80 years and older: a retrospective cohort study. PeerJ. 2025 Nov 19;13:e20404. doi: 10.7717/peerj.20404. eCollection 2025.
PubMed 41282981Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.
PubMed 28873161He KQ, Huang TT, Tan MY, Gao C, Wang S. Efficacy and Safety of Ciprofol Versus Propofol as Anesthetic for Patients Undergoing Painless Colonoscopy. Pain Ther. 2024 Dec;13(6):1633-1644. doi: 10.1007/s40122-024-00662-x. Epub 2024 Oct 14.
PubMed 39400664
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Exchange Colonoscopy in Elderly Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07830823
- Acronym / sponsor ID
- LY2024013K
- Conditions
- Colonoscopy, Colorectal Cancer Screening
- Keywords
- Water exchange colonoscopy, elderly patients, non-anesthesia, pain score, inflammatory mediators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- First People's Hospital Of Lin'an District, HangzhouUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 21 Sep 2026 (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 an important test for detecting colorectal polyps and cancer, but it can cause pain and discomfort, especially in older adults. Traditional colonoscopy uses air to expand the colon. Water exchange colonoscopy uses warm water instead of air, which may reduce pain and make the examination easier. This study compared four colonoscopy methods in patients aged 55 years and older: non-anesthesia water injection, non-anesthesia gas insufflation, anesthesia water injection, and anesthesia gas insufflation. Two hundred participants were randomly assigned to one of the four groups. The study measured pain using a visual analog scale, the time needed to reach the cecum, and blood levels of inflammatory markers (IL-1β, IL-6, and PGE2). The results may help doctors choose a safer and more comfortable colonoscopy method for older patients, especially when anesthesia may not be suitable.
Detailed description
Background: Colorectal cancer incidence and mortality increase with age, and colonoscopy is essential for screening and managing colorectal polyps. Conventional gas insufflation can cause abdominal distension, pain, and loop formation, particularly in elderly patients who often have relaxed abdominal muscles, elongated colons, and comorbidities that increase anesthesia risk. Water exchange colonoscopy has been reported to reduce pain by using warm water to navigate the colon without full gas distension.
Objective: To evaluate the clinical value of non-anesthesia water exchange colonoscopy in elderly patients and compare it with anesthesia water exchange, non-anesthesia gas insufflation, and anesthesia gas insufflation.
Methods: This was a single-center, prospective, randomized controlled trial that enrolled 200 patients aged 55 years or older undergoing colonoscopy between November 2024 and December 2025. Participants were randomly assigned (1:1:1:1) using a random number table to four groups (n=50 each): non-anesthesia water injection (NW), non-anesthesia gas insufflation (NA), anesthesia water injection (AW), and anesthesia gas insufflation (AA). All procedures were performed by an experienced endoscopist using a high-definition colonoscope (Olympus CF-HQ290I). Bowel preparation used standard polyethylene glycol electrolyte powder. In water injection groups, warm water at 37°C was injected through the biopsy channel during insertion, with suction of gas and fluid as needed. In gas insufflation groups, conventional air insufflation was used. Anesthesia groups received intravenous propofol combined with a small amount of opioid, administered by an anesthesiologist with continuous vital sign monitoring. The non-anesthesia groups received no anesthesia or analgesia.
Outcomes: The primary outcomes included maximum pain score during examination measured by a 10-point visual analog scale (VAS), cecal intubation time (minutes from insertion to identification of the ileocecal landmark), and serum levels of inflammatory and pain mediators (IL-1β, IL-6, and PGE2) measured by ELISA before and during colonoscopy. Non-inferiority of AW versus NW was assessed for inflammatory mediator inhibition using pre-specified margins. Statistical analysis used SPSS 25.0, with one-way ANOVA, Tukey HSD test, chi-square test, and non-inferiority testing; P<0.05 was considered statistically significant.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants were randomly assigned to one of four parallel groups (1:1:1:1 ratio): non-anesthesia water injection (NW), non-anesthesia gas insufflation (NA), anesthesia water injection (AW), and anesthesia gas insufflation (AA).
| Arm | Type | Receives |
|---|---|---|
| Non-anesthesia water injection (NW) | Experimental | Procedure: Water exchange colonoscopyParticipants receive water exchange colonoscopy without anesthesia. Warm water at 37°C is injected through the biopsy channel during insertion; gas and fluid are aspirated as needed. No anesthesia or analgesia is administered. |
| Non-anesthesia gas insufflation (NA) | Experimental | Procedure: Gas insufflation colonoscopyParticipants receive conventional gas insufflation colonoscopy without anesthesia. Air is used to expand the intestinal lumen. No anesthesia or analgesia is administered. |
| Anesthesia water injection (AW) | Experimental | Procedure: Water exchange colonoscopy, Drug: Propofol and opioid anesthesiaParticipants receive water exchange colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. |
| Anesthesia gas insufflation (AA) | Experimental | Procedure: Gas insufflation colonoscopy, Drug: Propofol and opioid anesthesiaParticipants receive conventional gas insufflation colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 55 years
- Indications for colonoscopy
- Signed informed consent form
Key exclusion criteria (3 listed)
- History of intestinal surgery
- Severe intestinal stenosis or obstruction
- Cognitive impairment that precludes cooperation with assessment
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 |
|---|---|---|
| Water exchange colonoscopyAlso: Water-aided colonoscopyDuring endoscope insertion, warm water at 37°C is injected through the biopsy channel to facilitate the procedure. Gas and liquid within the cavity are aspirated as thoroughly as possible. A minimal amount of gas is introduced for observation when necessary. | Procedure or surgery | Anesthesia water injection (AW), Non-anesthesia water injection (NW) |
| Gas insufflation colonoscopyAlso: Air insufflation colonoscopyConventional air insufflation is employed to expand the intestinal lumen, thereby aiding in endoscope insertion. | Procedure or surgery | Anesthesia gas insufflation (AA), Non-anesthesia gas insufflation (NA) |
| Propofol and opioid anesthesiaAlso: Intravenous anesthesiaIntravenous general anesthesia consisting of propofol combined with a small quantity of opioid drugs, administered by an anesthesiologist prior to the examination, with continuous monitoring of vital signs. | Drug | Anesthesia gas insufflation (AA), Anesthesia water injection (AW) |
Primary outcome
Serum inflammatory factors and pain mediators
Time frame: Baseline and periprocedural
Change from baseline in serum levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and prostaglandin E2 (PGE2) measured by ELISA before and during colonoscopy. Used for non-inferiority comparison between non-anesthesia water injection (NW) and anesthesia water injection (AW).
Pain score (VAS)
Time frame: Periprocedural
Maximum pain level during colonoscopy assessed by the patient using a visual analog scale (VAS, 0-10 points, where 0 indicates no pain and 10 signifies severe pain).
2 secondary outcomes
Cecal intubation time
Time frame: Periprocedural
Adverse events
Time frame: Periprocedural
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 21 Sep 2026.
- Results publication: PubMed 30632431Xu X, Ni D, Lu Y, Huang X. Diagnostic application of water exchange colonoscopy: A meta-analysis of randomized controlled trials. J Int Med Res. 2019 Feb;47(2):515-527. doi: 10.1177/0300060518819626. Epub 2019 Jan 11.
- Results publication: PubMed 33069706Cadoni S, Ishaq S, Hassan C, Falt P, Fuccio L, Siau K, Leung JW, Anderson J, Binmoeller KF, Radaelli F, Rutter MD, Sugimoto S, Muhammad H, Bhandari P, Draganov PV, de Groen P, Wang AY, Yen AW, Hamerski C, Thorlacius H, Neumann H, Ramirez F, Mulder CJJ, Albeniz E, Amato A, Arai M, Bak A, Barret M, Bayupurnama P, Cheung R, Ching HL, Cohen H, Dolwani S, Friedland S, Harada H, Hsieh YH, Hayee B, Kuwai T, Lorenzo-Zuniga V, Liggi M, Mizukami T, Mura D, Nylander D, Olafsson S, Paggi S, Pan Y, Parra-Blanco A, Ransford R, Rodriguez-Sanchez J, Senturk H, Suzuki N, Tseng CW, Uchima H, Uedo N, Leung FW. Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations. Gastrointest Endosc. 2021 Jun;93(6):1411-1420.e18. doi: 10.1016/j.gie.2020.10.011. Epub 2020 Oct 16.
- Results publication: PubMed 41282981Ding Y, Lin X. Outcomes and safety of colonoscopy in elderly patients aged 80 years and older: a retrospective cohort study. PeerJ. 2025 Nov 19;13:e20404. doi: 10.7717/peerj.20404. eCollection 2025.
- Results publication: PubMed 28873161Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.
- Results publication: PubMed 39400664He KQ, Huang TT, Tan MY, Gao C, Wang S. Efficacy and Safety of Ciprofol Versus Propofol as Anesthetic for Patients Undergoing Painless Colonoscopy. Pain Ther. 2024 Dec;13(6):1633-1644. doi: 10.1007/s40122-024-00662-x. Epub 2024 Oct 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.
Yongjian Liao, MD principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water exchange colonoscopy, Gas insufflation colonoscopy and Propofol and opioid anesthesia in people with Colonoscopy and Colorectal Cancer Screening, run by First People's Hospital Of Lin'an District, Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. 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 China. 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?
Serum inflammatory factors and pain mediators (time frame: Baseline and periprocedural). 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 NCT07830823, which also lists 5 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 21 Sep 2026.