PTSDSGB-PsychoEDNCT04582396
Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
A study testing stellate ganglion block injection, Normal saline injection and Psychoeducation in people with PTSD and Cardiac Arrest, run by Columbia University at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PTSD, Cardiac Arrest, Anxiety and Fear
- What is being tested?
- stellate ganglion block injection, Normal saline injection and Psychoeducation
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2021to 19 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Fluent in English or Spanish
- A diagnosis of cardiac arrest (CA)
- Admitted to the New York-Presbyterian Hospital
- Elevated symptoms of psychological distress a. PCL-5 > 32 with a minimum of 2 weeks after cardiac arrest
Who cannot join
- A prior SGB treatment
- Severe brain injury defined as Cerebral Performance Category Score ≥3, and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer
- Terminal non-cardiovascular illness (life expectancy <1 year)
- Severe mental illness requiring urgent psychiatric hospitalization
- Alcohol or substance abuse that would impede ability to complete study
- Unavailable for telephone and in-person follow-up
Show all 12Show fewer
- Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
- Pre-existing Horner's syndrome
- Pregnancy
- Current anticoagulant use
- History of a bleeding disorder
- Infection or mass at injection site
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center/New York Presbyterian
New York, New York, 10032
About this study
Official title: A Pilot Study of Stellate Ganglion Blockade + Psychoeducation to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA).
Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms.
Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.
Read the detailed description
Every year in the U.S., 500,000 people experience sudden cardiac arrest (CA), caused by electrical disturbances across cardiac tissue, leading to marked arrhythmia that ultimately results in the heart ceasing to pump blood to the brain, lungs, and other organs. Due to advances in bundled post-arrest care, cardio-cerebral resuscitation, and effective cooling protocols, a substantial proportion of patients who receive guideline-based care (nearly 1 in 3 for out-of-hospital and ~50% for in-hospital CA) now survive this once universally fatal condition. While most survivors retain their cognitive function and physical independence, many grapple with CA's psychological consequences in the context of learning that they were "clinically dead."
In particular, many describe the CA experience as traumatic, and up to 1 in 3 CA survivors subsequently develop posttraumatic stress disorder (PTSD). Not only is PTSD common in CA patients, but there is evidence that PTSD after CA may influence health behaviors and prognosis.
Treatment of early PTSD and cardiac anxiety symptoms after CA requires timely intervention. Recent studies show that SGB is a safe and acceptable intervention for reducing PTSD symptoms in combat veterans. SGB treatment has never been tested to treat PTSD induced by acute medical events such as CA.
- Conditions
- PTSD, Cardiac Arrest, Anxiety and Fear, Sleep Disturbance, Health Behavior
- Being tested
- stellate ganglion block injection, Normal saline injection, Psychoeducation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Heart Arrest, Anxiety Disorders, Parasomnias, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion block injectionProcedure or surgery
Also called SGB injection
A stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.
Normal saline injectionProcedure or surgery
Also called Sham procedure
An injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.
PsychoeducationBehavioural
The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior.
Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block + Psychoeducation | Experimental | For the active SGB arm, 7 to 8 mL of ropivacaine, 0.5%, will be injected around and into the site of the ganglion once before the hospital discharge. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients. Receives: Procedure: stellate ganglion block injection; Behavioral: Psychoeducation |
| Normal saline injection + Psychoeducation | Placebo comparator | For the sham procedure, 1 to 2 mL of preservative-free normal saline will be injected into deep musculature in the neck. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients. Receives: Procedure: Normal saline injection; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Subjects Who Get Enrolled in the Trial
This is designed to measure the feasibility of successful enrollment.
Measured: Baseline (pre-procedure)
Number of Patients Recruited Per Month
This is designed to measure the rate of enrollment, with <4 patients/month considered not meeting outcome
Measured: Assessed at 10 Month from the beginning of enrollment
Proportion of Participants Who Complete the 4-weeks Assessments
This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.
Measured: 4 weeks post-enrollment
Proportion of Participants Who Complete the 12-weeks Assessments
This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.
Measured: 12-weeks post-procedure
Horner's Syndrome
Horner syndrome is a condition that affects the face and eye on one side of the body, being caused by a disrupted nerve pathway from the brain to the head and neck. This syndrome can be assessed through a visual exam, involving the observation of decreased pupil size, a drooping eyelid and decreased sweating on the affected side of the face.
Measured: Immediately post-procedure
Treatment Expectancy Eligibility Questionnaire
This is a questionnaire that assesses the number of participants with credibility. Through this questionnaire, whether the participant will proceed through the study will be determined.
Measured: Immediately post-procedure
The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation
This is designed to assess the feasibility of administering psychoeducation, with >80% of the components in the checklist as a threshold for success.
Measured: Assessed at baseline post-procedure
Total Actigraph Wear Time
the proportion of participants with >80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy
Measured: Assessed at 4-weeks post-procedure
Secondary outcomes (6)
Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)
This is a 20-item self-report measure that assesses symptoms of PTSD. Each item can be scored on a scale of 0-4, "Not at all" (0), "A little bit" (1), "Moderately" (2), "Quite a bit" (3), and "Extremely" (4) are the eligible responses. There are five clusters that are assessed: items 1-5, items 6-7, items 8-14, and items 15-20. Each of these sub-scores are summed to receive a score between 0-80; a higher score indicating a higher severity of PTSD symptoms. The cutoff score that is indicative of probable PTSD is 31-33.
Measured: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety
The effect of SGB-PsychoED intervention on cardiac anxiety will be assessed using cardiac anxiety questionnaire (CAQ).This is an 18-item questionnaire that assesses anxiety through three divided sub-scales: fear (items 10, 11, 13-18), avoidance (items 2, 5, 7, 9, 12), and attention (items 1, 3, 4, 6, 8). Each item is scored via the 5-point Likert scale: "Never" (0), "Rarely" (1). "Sometimes" (2), "Often" (3), and "Always" (4). Item responses are summed to receive a score between 0-72. Higher reported scores indicate a greater heart-focused anxiety.
Measured: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.
The effect of the intervention on generalized anxiety disorder will be assessed using the generalized anxiety disorder scale-7 (GAD-7). This is a 7-item scale that assesses the presence of generalized anxiety disorder. Responses can be given as "Not at all" (0), "Several days" (1), "More than half the days" (2), and "Nearly every day" (3). These scores can be summed to produce a score between 0 and 21. Scores between 0-4 indicate minimal anxiety, scores between 5-9 indicate mild anxiety, scores between 10-14 indicate moderate anxiety, and scores greater than 15 indicate severe anxiety.
Measured: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Depression.
The effect of SGB-PsychoED intervention on depression will be assessed using the eight-item Patient Health Questionnaire depression scale (PHQ-8). This is an 8-item scale that assesses depression, with responses to each item being: "Not at all" (0), "Several days" (1), "More than half the days" (2), and "Nearly every day" (3). The sub-scores are summed to result in a score from 0-24. Higher scores indicate higher indication of depression. Scores that are reported as 10 or above are assessed to be showing symptoms of depression.
Measured: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Moderate to High Levels of Physical Activity.
Effect of SGB-PsychoED intervention on mean minutes/day of physical activity as measured by the objective actigraphy data
Measured: Assessed at 4-weeks post-discharge
The Proportion of Participants With Reduced Duration of Sleep.
Effect of SGB-PsychoED intervention on mean hours/day of sleep as measured by the objective actigraphy data
Measured: Assessed at 4-weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start11 Mar 2021
- Primary completion19 Apr 2021
- Study completion19 Apr 2021
Why it stopped: majority of the participants had exclusion criteria of anticoagulant use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot RCT to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade and psychoeducation vs sham-procedure and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sachin Agarwal, Columbia University
- Investigators
- Sachin Agarwal, MD, MPH, Principal investigator, Columbia University/New York PresbyterianIan M Kronish, MD, MPH, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582396
- Sponsor's protocol ID
- AAAS8305
- Other IDs
- 5P30AG064198-02
- Acronym
- SGB-PsychoED
- Status last verified
- Jul 2024
- First submitted
- 5 Oct 2020
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available upon request to the study principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Stellate Ganglion Blockade + Psychoeducation to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors
- ClinicalTrials.gov ID
- NCT04582396
- Acronym / sponsor ID
- SGB-PsychoED / AAAS8305
- Conditions
- PTSD, Cardiac Arrest, Anxiety and Fear, Sleep Disturbance, Health Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: majority of the participants had exclusion criteria of anticoagulant use
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 19 Apr 2021 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA).
Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms.
Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.
Detailed description
Every year in the U.S., 500,000 people experience sudden cardiac arrest (CA), caused by electrical disturbances across cardiac tissue, leading to marked arrhythmia that ultimately results in the heart ceasing to pump blood to the brain, lungs, and other organs. Due to advances in bundled post-arrest care, cardio-cerebral resuscitation, and effective cooling protocols, a substantial proportion of patients who receive guideline-based care (nearly 1 in 3 for out-of-hospital and ~50% for in-hospital CA) now survive this once universally fatal condition. While most survivors retain their cognitive function and physical independence, many grapple with CA's psychological consequences in the context of learning that they were "clinically dead."
In particular, many describe the CA experience as traumatic, and up to 1 in 3 CA survivors subsequently develop posttraumatic stress disorder (PTSD). Not only is PTSD common in CA patients, but there is evidence that PTSD after CA may influence health behaviors and prognosis.
Treatment of early PTSD and cardiac anxiety symptoms after CA requires timely intervention. Recent studies show that SGB is a safe and acceptable intervention for reducing PTSD symptoms in combat veterans. SGB treatment has never been tested to treat PTSD induced by acute medical events such as CA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot RCT to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade and psychoeducation vs sham-procedure and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest.
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block + Psychoeducation | Experimental | Procedure: stellate ganglion block injection, Behavioral: PsychoeducationFor the active SGB arm, 7 to 8 mL of ropivacaine, 0.5%, will be injected around and into the site of the ganglion once before the hospital discharge. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients. |
| Normal saline injection + Psychoeducation | Placebo comparator | Procedure: Normal saline injection, Behavioral: PsychoeducationFor the sham procedure, 1 to 2 mL of preservative-free normal saline will be injected into deep musculature in the neck. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Fluent in English or Spanish
- A diagnosis of cardiac arrest (CA)
- Admitted to the New York-Presbyterian Hospital
- Elevated symptoms of psychological distress a. PCL-5 > 32 with a minimum of 2 weeks after cardiac arrest
Key exclusion criteria (12 listed)
- A prior SGB treatment
- Severe brain injury defined as Cerebral Performance Category Score ≥3, and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer
- Terminal non-cardiovascular illness (life expectancy <1 year)
- Severe mental illness requiring urgent psychiatric hospitalization
- Alcohol or substance abuse that would impede ability to complete study
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 |
|---|---|---|
| stellate ganglion block injectionAlso: SGB injectionA stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting. | Procedure or surgery | Stellate Ganglion Block + Psychoeducation |
| Normal saline injectionAlso: Sham procedureAn injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting. | Procedure or surgery | Normal saline injection + Psychoeducation |
| PsychoeducationThe session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior. Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA | Behavioural | Normal saline injection + Psychoeducation, Stellate Ganglion Block + Psychoeducation |
Primary outcome
Proportion of Eligible Subjects Who Get Enrolled in the Trial
Time frame: Baseline (pre-procedure)
This is designed to measure the feasibility of successful enrollment.
Number of Patients Recruited Per Month
Time frame: Assessed at 10 Month from the beginning of enrollment
This is designed to measure the rate of enrollment, with <4 patients/month considered not meeting outcome
Proportion of Participants Who Complete the 4-weeks Assessments
Time frame: 4 weeks post-enrollment
This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.
Proportion of Participants Who Complete the 12-weeks Assessments
Time frame: 12-weeks post-procedure
This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.
Horner's Syndrome
Time frame: Immediately post-procedure
Horner syndrome is a condition that affects the face and eye on one side of the body, being caused by a disrupted nerve pathway from the brain to the head and neck. This syndrome can be assessed through a visual exam, involving the observation of decreased pupil size, a drooping eyelid and decreased sweating on the affected side of the face.
Treatment Expectancy Eligibility Questionnaire
Time frame: Immediately post-procedure
This is a questionnaire that assesses the number of participants with credibility. Through this questionnaire, whether the participant will proceed through the study will be determined.
The Proportion of Participants Completing the Check-list of Various Components of Psychoeducation
Time frame: Assessed at baseline post-procedure
This is designed to assess the feasibility of administering psychoeducation, with >80% of the components in the checklist as a threshold for success.
Total Actigraph Wear Time
Time frame: Assessed at 4-weeks post-procedure
the proportion of participants with >80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy
6 secondary outcomes
Number of Participants With Posttraumatic Stress Disorder Using Posttraumatic Stress Disorder (PCL-5)
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Cardiac Anxiety
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Generalized Anxiety Disorder.
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Clinically Significant Symptoms of Depression.
Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure
The Proportion of Participants With Moderate to High Levels of Physical Activity.
Time frame: Assessed at 4-weeks post-discharge
The Proportion of Participants With Reduced Duration of Sleep.
Time frame: Assessed at 4-weeks post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be made available upon request to the study principal investigator.
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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.
Sachin Agarwal, MD, MPH principal investigator
Columbia University/New York Presbyterian
Ian M Kronish, MD, MPH study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stellate ganglion block injection, Normal saline injection and Psychoeducation in people with PTSD and Cardiac Arrest, run by Columbia University 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 5 inclusion and 12 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 31 Jul 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?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eligible Subjects Who Get Enrolled in the Trial (time frame: Baseline (pre-procedure)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2024.