Procedural AnxietyVRIPanx-COLNCT06346171
VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain
A study testing Virtual Reality Integrative Psychotherapy and Virtual Reality Distraction in people with Procedural Anxiety and Procedural Pain, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Anxiety, Procedural Pain
- What is being tested?
- Virtual Reality Integrative Psychotherapy and Virtual Reality Distraction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jun 2024to 14 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled non-sedated colonoscopy.
- cognitive ability to understand study aims;
- willingness to participate and provide written consent.
Who cannot join
- emergency colonoscopy;
- significant sensory-cognitive impairments;
- potential risk of:
- photic seizures;
- photosensitivity;
- severe motion sickness;
Show all 10Show fewer
- allergies to materials used.
- anxiety disorders:
- use of psychoactive or analgesic substances;
- concomitant psychotherapy.
Trial locations and contacts
1 site in 1 country.
Romania1 site
University of Medicine and Pharmacy Grigore T Popa
Iași, Iaşi, 700115
About this study
Official title: Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain: A Prevalidation Trial Protocol (VRIPanx-COL)
Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes.
Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures.
Read more
The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction.
Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality.
Read the detailed description
The proposed VR-Facilitated Integrative Psychotherapy framework (VRIPainX-COL) leverages the immersive capabilities of VR as platform fir psychological interventions for this pilot trial is designed to assess its preliminary efficacy, acceptability, and feasibility in reducing the pre-procedural anxiety and discomfort associated with colonoscopy.
Primary Aims:
1.1 Developing a comprehensive conceptual framework for colonoscopy procedural anxiety and pain reduction through a a humanised digital interface using virtual reality distraction as platform for integrative psychotherapy support VRIPanx-COL; 1.2 Clinically implementing the VRIPanx-COL blueprint within a methodological design aimed at assessing its preliminary efficacy in reducing perceived procedural anxiety and pain compared to 1.3 VR distraction alone and 1.4 conventional non-sedated colonoscopy
Secondary Aims:
2.1 Evaluate the feasibility and acceptability of implementing VRIP-Col interventions during non-sedated colonoscopy, 2.2 Gathering qualitative feedback from both patients and performing colonoscopists regarding VRIP experienced advantages, obstacles and their perspectives for enhancing the intervention.
- Conditions
- Procedural Anxiety, Procedural Pain
- Being tested
- Virtual Reality Integrative Psychotherapy, Virtual Reality Distraction
- Keywords
- colonoscopy, anxiety, pain, virtual reality, psychotherapy
- Medical subject headings
- Pain, Procedural, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Integrative PsychotherapyBehavioural
Also called VRIP
Music therapy: "Weightless" by Marconi Union plays continuously, bridging VR distraction and psychotherapy.
Before: Patients pick a VR scene (-13 to -10 min), learn VR navigation, and practice 4-7-8 breathing with a VR flower for grounding and resilience (-10 to -9 min). They continue 4-7-8 doing Progressive Muscle Relaxation (4+7 contraction, 8 relaxation), moving from lower body to facial muscles (-8 to -5 min). Values and commitment to action are discussed (-4 to -2 min), emphasizing present-focused thoughts and acceptance (-1 min).
During: Mindfulness and relaxation are encouraged, with PMR during intense moments. Empowerment and procedural feedback are provided (0 to 30/45 min).
After: Debriefing normalizes the experience, reinforcing proactive health actions (35 to 50 min).
Virtual Reality DistractionDevice
Also called VRD
Software: Nature Treks VR nature environments. Hardware: dedicated head-mounted VR display (Oculus Rift S.) powered by a high-end computer (Laptop with at least GTX 1080 graphics card, both with processing units that lower the bottleneck chances); minimum specifications should facilitate presence while limiting cybersickness by ensuring refresh rates beyound 85 frames/second.
Music therapy: "Weightless" by Marconi Union plays continuously, facilitating sensorial distraction while also allowing blinding.
Although the psychotherapist will interact with the patient, the dialogue will exclude psychotherapic approaches. The dialogue is designed to be neutral, resembling a comprehensive tutorial for the VR experience. This serves as a comparator to assess the added value of integrating psychotherapeutic techniques within the VR experience.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Integrative Psychotherapy | Experimental | This group will undergo the same virtual reality exposure software during the colonoscopy procedure, but the psychotherapist will implement the integrative psychotherapy framework during the procedure. Receives: Behavioral: Virtual Reality Integrative Psychotherapy; Device: Virtual Reality Distraction |
| Virtual Reality Distraction | Sham comparator | This group will be exposed to the virtual reality environment as a distraction, but although receiving support in exploring the virtual world, no psychotherapy techniques will implemented. Receives: Device: Virtual Reality Distraction |
| Control group | No intervention | This group will undergo treatment as usual according to state-of-the-art guidelines for non-sedated colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Procedure-Related Anxiety
This measure assesses the degree of reduction in anxiety related to undergoing a non-sedated colonoscopy procedure. Anxiety levels will be quantified using the Spielberger STAI-Y1 and STAI-Y2 forms, previously standardized to the Romanian population and approved by Romanian Psychological College. STAI-Y1 and Y2 are applied and interpreted by a licensed investigator, in order to ensure viability of collected data. The scale measures how respondents feel at a particular moment in time and in general, providing insight into both state and trait anxiety levels. The difference in STAI-Y1 scores from baseline (pre-intervention) to post-procedure will be analyzed to determine the effectiveness of the VR-Augmented Integrative Psychotherapy in reducing procedural anxiety compared to Sham VR Distraction and control groups.
Measured: STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion).
Pain perception
The primary measure of pain perception will be the Visual Analog Scale (VAS), a validated tool for pain assessment. This self-reported measure allows patients to rate their pain on a scale from "no pain" (0) to "worst imaginable pain" (10).
Measured: Within 20 minutes before the colonoscopy procedure (baseline) and immediately after the procedure (within 20 minutes post-procedure).
Secondary outcomes (2)
Feasibility and Acceptability of VRIP-Col Interventions
This outcome will assess the logistical feasibility and overall acceptability of the VRIP-Col interventions among patients undergoing non-sedated colonoscopy. Feasibility metrics will include the successful integration of VRIP-Col into clinical workflows, the ability to deliver the intervention to all enrolled participants without disrupting standard care procedures, and the technical reliability of VR equipment. Acceptability will be evaluated through patient and healthcare provider satisfaction surveys, focusing on the perceived usefulness, ease of use, and willingness to use or recommend the VRIP-Col interventions in the future.
Measured: Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
Qualitative Feedback on VRIP-Col Interventions
This outcome will involve the collection and analysis of qualitative feedback from patients who receive the VRIP-Col interventions and the colonoscopists who perform the procedures. Feedback will be gathered through semi-structured interviews designed to explore the perceived advantages of the VRIP-Col interventions, any obstacles encountered during their implementation, and suggestions for improvement from both the patient and provider perspectives. This qualitative analysis will provide insights into the user experience, identify potential barriers to effective implementation, and inform future refinements of the VRIP-Col approach.
Measured: Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jun 2024
- Primary completion31 Aug 2024
- Study completion14 Sep 2024
Why it stopped: Pilot trial terminated early after confirming feasibility with no adverse events; transition planned to fully powered RCT. Conclusion also required following the sudden passing of lead investigator Prof. Dr. Gabriela Ștefănescu.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies 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
- Model description
- The VRIPanx-COL study is an RCT investigating the efficacy of VR-facilitated integrative psychotherapy compared to VR distraction only and NSE-Col. Variance minimisation and propensity score matching are used to ensure that the groups are balanced and to supplement the internal validity of evaluating the efficacy of the intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcel-Alexandru Gaina, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Marcel A Gaina, ass.prof. MD, Study director, University of Medicine and Pharmacy "Grigore T Popa" Iasi, RomaniaCristinel Stefanescu, Prof. MD, Study chair, University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346171
- Sponsor's protocol ID
- 408/06.03.2024
- Acronym
- VRIPanx-COL
- Status last verified
- Aug 2025
- First submitted
- 28 Mar 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the conclusion and dissemination of the primary results of our study, we are committed to sharing the IPD and its supplementary documentation - including the study protocol, statistical analysis plan, informed consent form, and the clinical study report - with qualified investigators bestowing a scientifically valid analysis proposal.
Publications
Gaina MA, Szalontay AS, Stefanescu G, Balan GG, Ghiciuc CM, Bolos A, Gaina AM, Stefanescu C. State-of-the-Art Review on Immersive Virtual Reality Interventions for Colonoscopy-Induced Anxiety and Pain. J Clin Med. 2022 Mar 17;11(6):1670. doi: 10.3390/jcm11061670.
PubMed 35329993
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Virtual Reality Augmented Clinician-Delivered Integrative Psychotherapy Model for Non-Sedated Colonoscopy Procedural Anxiety and Pain: A Prevalidation Trial Protocol (VRIPanx-COL)
- ClinicalTrials.gov ID
- NCT06346171
- Acronym / sponsor ID
- VRIPanx-COL / 408/06.03.2024
- Conditions
- Procedural Anxiety, Procedural Pain
- Keywords
- colonoscopy, anxiety, pain, virtual reality, psychotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pilot trial terminated early after confirming feasibility with no adverse events; transition planned to fully powered RCT. Conclusion also required following the sudden passing of lead investigator Prof. Dr. Gabriela Ștefănescu.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 3 Apr 2024 (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 invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes.
Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures.
The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction.
Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality.
Detailed description
The proposed VR-Facilitated Integrative Psychotherapy framework (VRIPainX-COL) leverages the immersive capabilities of VR as platform fir psychological interventions for this pilot trial is designed to assess its preliminary efficacy, acceptability, and feasibility in reducing the pre-procedural anxiety and discomfort associated with colonoscopy.
Primary Aims:
1.1 Developing a comprehensive conceptual framework for colonoscopy procedural anxiety and pain reduction through a a humanised digital interface using virtual reality distraction as platform for integrative psychotherapy support VRIPanx-COL; 1.2 Clinically implementing the VRIPanx-COL blueprint within a methodological design aimed at assessing its preliminary efficacy in reducing perceived procedural anxiety and pain compared to 1.3 VR distraction alone and 1.4 conventional non-sedated colonoscopy
Secondary Aims:
2.1 Evaluate the feasibility and acceptability of implementing VRIP-Col interventions during non-sedated colonoscopy, 2.2 Gathering qualitative feedback from both patients and performing colonoscopists regarding VRIP experienced advantages, obstacles and their perspectives for enhancing the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The VRIPanx-COL study is an RCT investigating the efficacy of VR-facilitated integrative psychotherapy compared to VR distraction only and NSE-Col. Variance minimisation and propensity score matching are used to ensure that the groups are balanced and to supplement the internal validity of evaluating the efficacy of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Integrative Psychotherapy | Experimental | Behavioral: Virtual Reality Integrative Psychotherapy, Device: Virtual Reality DistractionThis group will undergo the same virtual reality exposure software during the colonoscopy procedure, but the psychotherapist will implement the integrative psychotherapy framework during the procedure. |
| Virtual Reality Distraction | Sham comparator | Device: Virtual Reality DistractionThis group will be exposed to the virtual reality environment as a distraction, but although receiving support in exploring the virtual world, no psychotherapy techniques will implemented. |
| Control group | No intervention | –This group will undergo treatment as usual according to state-of-the-art guidelines for non-sedated colonoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled non-sedated colonoscopy.
- cognitive ability to understand study aims;
- willingness to participate and provide written consent.
Key exclusion criteria (10 listed)
- emergency colonoscopy;
- significant sensory-cognitive impairments;
- potential risk of:
- anxiety disorders:
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 |
|---|---|---|
| Virtual Reality Integrative PsychotherapyAlso: VRIPMusic therapy: "Weightless" by Marconi Union plays continuously, bridging VR distraction and psychotherapy. Before: Patients pick a VR scene (-13 to -10 min), learn VR navigation, and practice 4-7-8 breathing with a VR flower for grounding and resilience (-10 to -9 min). They continue 4-7-8 doing Progressive Muscle Relaxation (4+7 contraction, 8 relaxation), moving from lower body to facial muscles (-8 to -5 min). Values and commitment to action are discussed (-4 to -2 min), emphasizing present-focused thoughts and acceptance (-1 min). During: Mindfulness and relaxation are encouraged, with PMR during intense moments. Empowerment and procedural feedback are provided (0 to 30/45 min). After: Debriefing normalizes the experience, reinforcing proactive health actions (35 to 50 min). | Behavioural | Virtual Reality Integrative Psychotherapy |
| Virtual Reality DistractionAlso: VRDSoftware: Nature Treks VR nature environments. Hardware: dedicated head-mounted VR display (Oculus Rift S.) powered by a high-end computer (Laptop with at least GTX 1080 graphics card, both with processing units that lower the bottleneck chances); minimum specifications should facilitate presence while limiting cybersickness by ensuring refresh rates beyound 85 frames/second. Music therapy: "Weightless" by Marconi Union plays continuously, facilitating sensorial distraction while also allowing blinding. Although the psychotherapist will interact with the patient, the dialogue will exclude psychotherapic approaches. The dialogue is designed to be neutral, resembling a comprehensive tutorial for the VR experience. This serves as a comparator to assess the added value of integrating psychotherapeutic techniques within the VR experience. | Device | Virtual Reality Distraction, Virtual Reality Integrative Psychotherapy |
Primary outcome
Reduction in Procedure-Related Anxiety
Time frame: STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion).
This measure assesses the degree of reduction in anxiety related to undergoing a non-sedated colonoscopy procedure. Anxiety levels will be quantified using the Spielberger STAI-Y1 and STAI-Y2 forms, previously standardized to the Romanian population and approved by Romanian Psychological College. STAI-Y1 and Y2 are applied and interpreted by a licensed investigator, in order to ensure viability of collected data. The scale measures how respondents feel at a particular moment in time and in general, providing insight into both state and trait anxiety levels. The difference in STAI-Y1 scores from baseline (pre-intervention) to post-procedure will be analyzed to determine the effectiveness of the VR-Augmented Integrative Psychotherapy in reducing procedural anxiety compared to Sham VR Distraction and control groups.
Pain perception
Time frame: Within 20 minutes before the colonoscopy procedure (baseline) and immediately after the procedure (within 20 minutes post-procedure).
The primary measure of pain perception will be the Visual Analog Scale (VAS), a validated tool for pain assessment. This self-reported measure allows patients to rate their pain on a scale from "no pain" (0) to "worst imaginable pain" (10).
2 secondary outcomes
Feasibility and Acceptability of VRIP-Col Interventions
Time frame: Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
Qualitative Feedback on VRIP-Col Interventions
Time frame: Data on feasibility and acceptability will be collected within 24 hours after the colonoscopy procedure.
Results and safety
The study was stopped early (reason given: Pilot trial terminated early after confirming feasibility with no adverse events; transition planned to fully powered RCT. Conclusion also required following the sudden passing of lead investigator Prof. Dr. Gabriela Ștefănescu.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 35329993Gaina MA, Szalontay AS, Stefanescu G, Balan GG, Ghiciuc CM, Bolos A, Gaina AM, Stefanescu C. State-of-the-Art Review on Immersive Virtual Reality Interventions for Colonoscopy-Induced Anxiety and Pain. J Clin Med. 2022 Mar 17;11(6):1670. doi: 10.3390/jcm11061670.
- Individual participant dataSharing planned: Yes. Following the conclusion and dissemination of the primary results of our study, we are committed to sharing the IPD and its supplementary documentation - including the study protocol, statistical analysis plan, informed consent form, and the clinical study report - with qualified investigators bestowing a scientifically valid analysis proposal.
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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.
Marcel A Gaina, ass.prof. MD study director
University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania
Cristinel Stefanescu, Prof. MD study chair
University of Medicine and Pharmacy "Grigore T Popa" Iasi, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Integrative Psychotherapy and Virtual Reality Distraction in people with Procedural Anxiety and Procedural Pain, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 10 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: stopped early, as of the sponsor's last update on 30 Jul 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 Romania. 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 stopped early (reason given: Pilot trial terminated early after confirming feasibility with no adverse events; transition planned to fully powered RCT. Conclusion also required following the sudden passing of lead investigator Prof. Dr. Gabriela Ștefănescu.). Results are not available in the source record.
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?
Reduction in Procedure-Related Anxiety (time frame: STAY-Y1: baseline anxiety measured within 20 minutes before the procedure; post-procedural anxiety (within 20 minutes after the procedure's completion).). 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 NCT06346171, which also lists 1 linked publication.
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 30 Jul 2026.