Low Anterior Resection SyndromePOLARiSNCT05319054
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
A study testing Sacral NeuroModulation, Trans-Anal Irrigation and Optimised Conservative Management in people with Low Anterior Resection Syndrome, run by Cardiff and Vale University Health Board at 4 sites in United Kingdom.
Trial summary
Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Sacral NeuroModulation, Trans-Anal Irrigation and Optimised Conservative Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 23 May 2022to 30 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For cohort:
- Diagnosis of rectal or sigmoid cancer
- Low or high anterior resection (colorectal resection with anastomosis to the rectum)
- Functioning anastomosis
- Aged 18 years and older
- Primary surgery/reversal of ileostomy less than 10 years before recruitment
Show all 13Show fewer
- Reversal of ileostomy at least 12 weeks prior to recruitment with at least a further 12 weeks of standard care to manage symptoms following reversal
- Willing and able to provide valid informed consent
- For randomisation:
- Recruited to cohort study
- Willing and able to provide valid informed consent for randomisation
- Major LARS symptoms (Defined as score of 30+ on LARS scoring tool)
- Previous unsuccessful conservative treatment determined by treating clinician and patient
Who cannot join
- For cohort
- Inability to understand and complete study questionnaires independently. (Due to cognitive or intellectual impairment, Due to insufficient English language skills)
- For randomised control trial
- Pregnancy
- No previous conservative treatment plan for the management of LARS
- Does not meet any treatment-specific criteria
Show all 19Show fewer
- For TAI randomisation:
- Unable to perform TAI
- History of anastomotic leak with evidence of ongoing leak/sinus
- Previous use of TAI for LARS
- Site unable to offer TAI as a treatment
- Any other contraindications advised by the care team, product manufacturer or distributor
- For SNM randomisation:
- <12months since primary cancer surgery
- Palliative disease
- Site unable to offer SNM as a treatment
- Previous SNM
- Specific contraindications to implantation
- Any other contraindications advised by the care team, product manufacturer or distributor.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Julie Cornish
Cardiff, CF14 4XW
Leeds Teaching Hospital NHS Trust
Leeds, Yorkshire, LS9 7TF
Royal Gwent Hospital
Newport, NP20 2UB
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: A Feasibility, Multicentre Randomised Control Trial Assessing the Treatment Options for Patient With Major Low Anterior Resection Syndrome to Establish a Pathway Of Low Anterior Resection Syndrome Relief After Surgery
Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial.
Read the detailed description
Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these patients is surgical removal of the affected part of the bowel, following which the bowel is joined back together. Some patients may also require chemotherapy and radiotherapy. One consequence of the treatment of bowel cancer is a severe form of bowel dysfunction called major Low Anterior Resection Syndrome (LARS).
LARS is a constellation of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation; it is diagnosed using the LARS scoring tool. Major LARS can have a huge impact on the persons quality of life resulting in social isolation. Currently there are no guidelines for the management of LARS. The aim of the POLARiS study is to investigate three different treatments for major LARS; optimised conservative management, a combination of diet, medication, bowel retraining and pelvic floor exercises; transanal irrigation, washing out the back passage of stool with warmed water; and sacral nerve stimulation where an electrical impulse delivered to the sacral nerve to help with bowel function. This feasibility study aims to test the study design ahead of a larger fully powered randomised control trial. The study will firstly recruit any consenting adult who has had surgery for rectal cancer (called an anterior resection) and who does not have a stoma, into a cohort and then follow up those patients every 3 months with bowel function and quality of life assessments. Any patient found to have major LARS (LARS score over 30) will be invited into the randomised control trial where the above three treatments will be tested.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Sacral NeuroModulation, Trans-Anal Irrigation, Optimised Conservative Management
- Keywords
- Sacral Neuromodulation, Transanal Irrigation, Trials within cohorts, Colorectal cancer, Quality of Life
- Medical subject headings
- Low Anterior Resection Syndrome, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral NeuroModulationDevice
Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.
Trans-Anal IrrigationDevice
Trans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference.
Optimised Conservative ManagementOther
Optimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | No intervention | Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals. |
| Optimised Conservative Management | Active comparator | Cohort participants who are identified as having 'major LARS' at any point are treated with Optimised Conservative Managements, consisting of medication, dietary advice, lifestyle advice and physiotherapy. Receives: Other: Optimised Conservative Management |
| Trans-Anal Irrigation | Active comparator | Cohort participants who are identified as having 'major LARS' at any point are treated with Trans-anal irrigation, in additional to receiving optimised conservative management. Transanal irrigation system will be decided upon with the participant and procured locally. Receives: Device: Trans-Anal Irrigation; Other: Optimised Conservative Management |
| Sacral NeuroModulation | Active comparator | Cohort participants who are identified as having 'major LARS' at any point are treated with Sacral Neuromodulation system, in addition to receiving optimised conservative management. Medtronic Interstim system will be used. Receives: Device: Sacral NeuroModulation; Other: Optimised Conservative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate of to cohort arm of study
The total number of participants enrolled into the study over the recruitment period.
Measured: 9 months
Assess characteristics of patients recruited to the cohort
We will record basic demographics, medical history and prevalence of relative symptoms of participants enrolled in the cohort study to describe the characteristics of no- minor- and major- LARS patients
Measured: 9 months
Prevalence of 'major LARS' in the patient cohort
The number of participants in the cohort that meet the criteria for 'major low anterior resection syndrome (LARS)', as measured by the LARS scoring tool. LARS scoring tool produces a score from 0 - 42, which represents the severity of symptoms, where 0 is least severe and 42 is most severe. Score =>30 is considered 'major LARS'. LARS score will be measured at 5 times at 3-monthly intervals over 12 months.
Measured: 12 months
Onset of 'major LARS' symptoms in relation to surgery
The time (in months) from resection surgery to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.
Measured: Time from surgery to onset of major LARS, up to 10 years.
Onset of 'major LARS' symptoms in relation to radiotherapy treatment
The time (in months) from completing radiotherapy treatment to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.
Measured: Time from ending radiotherapy treatment to onset of major LARS, up to 10 years.
Recruitment rate to randomised trial part of the study
The total number of cohort participants that are enrolled into the randomised trial part of the study, over the recruitment period.
Measured: 9 months
Proportion of randomised participants that are allocated to each trial arm
The proportion of randomised participants that meet the criteria for, and are allocated to, each of the three trial arms (transanal irrigation; sacral neuromodulation; optimised conservative management).
Measured: 9 months
Describe variation in clinical practice across UK sites
Where possible, we will record patient's previous treatments and interactions with health services in relation to their bowel dysfunction symptoms. This will be used to describe the variation in UK clinical practice in terms of diagnosis, management and treatment pathways.
Measured: Up to 10 years prior to recruitment
Compliance of participants to the study programme
The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).
Measured: 12 months
Adherence of participants to the treatment programme
The proportion of patients that continue to receive the treatment assigned to them at the end of the follow-up period.
Measured: 12 months
Secondary outcomes (7)
Change in LARS score
LARS score will be measured at 5 time points (at 3-monthly intervals from baseline to 12 months) to assess severity of bowel dysfunction. Self-reported by participants using the LARS scoring tool (min 0, max 42) where higher score denotes greater severity of symptoms.
Measured: 12 months.
Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)
Patient-reported quality of life will be measured using the EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L) at 5 time-points (3-monthly intervals from baseline to 12 months). Quality of life total score will be calculated (min 5; max 25), where reduction in total score represents improvement in quality of life.
Measured: 12 months
Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire
Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire (EORTC QLQ-CR29) at 5 time-points (3-monthly intervals, from baseline to 12 months). Quality of life total score will be calculated (min 26; max 104) where reduction in total score represents improvement in quality of life.
Measured: 12 months
Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire
Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This will be recorded at 5 time-points (3-monthly intervals, from baseline to 12 months). Total score will be calculated (min 30; max 128), where reduction in total score represents improvement in quality of life.
Measured: 12 months
Change in medical outcome profile score
Measure Yourself Medical Outcome Profile (MYMOP) 2 will be used to record patient-reported medical outcome profile at 5 time-points (3-montly intervals from baseline to 12 months). Change in patient-reported severity (min 0; max 5) will be measured, where change ≥ 1.0 is considered clinically significant.
Measured: 12 months
Patient-reported adverse events
We will record any adverse events reported by randomised patients in relation to each of the treatments they receive, which impairs their adherence to the study protocol, treatment programme or safety.
Measured: 12 months
LARS treatment history
Treatments offered to manage individual patient's LARS symptoms will be recorded, along with duration of treatment and reasons for stopping. This will be used to support the description of standard care variation and patient characteristics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start23 May 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trials within Cohorts
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- University of Leeds, Aneurin Bevan University Health Board, University Hospital Southampton NHS Foundation Trust, Bowel Research UK, The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Julie A Cornish, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319054
- Sponsor's protocol ID
- 8238
- Other IDs
- 307764
- Acronym
- POLARiS
- Status last verified
- Nov 2022
- First submitted
- 1 Apr 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Multicentre Randomised Control Trial Assessing the Treatment Options for Patient With Major Low Anterior Resection Syndrome to Establish a Pathway Of Low Anterior Resection Syndrome Relief After Surgery
- ClinicalTrials.gov ID
- NCT05319054
- Acronym / sponsor ID
- POLARiS / 8238
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Sacral Neuromodulation, Transanal Irrigation, Trials within cohorts, Colorectal cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- University of Leeds, Aneurin Bevan University Health Board, University Hospital Southampton NHS Foundation Trust, Bowel Research UK, The Leeds Teaching Hospitals NHS Trust
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Apr 2022 (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.
Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial.
Detailed description
Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these patients is surgical removal of the affected part of the bowel, following which the bowel is joined back together. Some patients may also require chemotherapy and radiotherapy. One consequence of the treatment of bowel cancer is a severe form of bowel dysfunction called major Low Anterior Resection Syndrome (LARS).
LARS is a constellation of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation; it is diagnosed using the LARS scoring tool. Major LARS can have a huge impact on the persons quality of life resulting in social isolation. Currently there are no guidelines for the management of LARS. The aim of the POLARiS study is to investigate three different treatments for major LARS; optimised conservative management, a combination of diet, medication, bowel retraining and pelvic floor exercises; transanal irrigation, washing out the back passage of stool with warmed water; and sacral nerve stimulation where an electrical impulse delivered to the sacral nerve to help with bowel function. This feasibility study aims to test the study design ahead of a larger fully powered randomised control trial. The study will firstly recruit any consenting adult who has had surgery for rectal cancer (called an anterior resection) and who does not have a stoma, into a cohort and then follow up those patients every 3 months with bowel function and quality of life assessments. Any patient found to have major LARS (LARS score over 30) will be invited into the randomised control trial where the above three treatments will be tested.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Trials within Cohorts
| Arm | Type | Receives |
|---|---|---|
| Cohort | No intervention | –Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals. |
| Optimised Conservative Management | Active comparator | Other: Optimised Conservative ManagementCohort participants who are identified as having 'major LARS' at any point are treated with Optimised Conservative Managements, consisting of medication, dietary advice, lifestyle advice and physiotherapy. |
| Trans-Anal Irrigation | Active comparator | Device: Trans-Anal Irrigation, Other: Optimised Conservative ManagementCohort participants who are identified as having 'major LARS' at any point are treated with Trans-anal irrigation, in additional to receiving optimised conservative management. Transanal irrigation system will be decided upon with the participant and procured locally. |
| Sacral NeuroModulation | Active comparator | Device: Sacral NeuroModulation, Other: Optimised Conservative ManagementCohort participants who are identified as having 'major LARS' at any point are treated with Sacral Neuromodulation system, in addition to receiving optimised conservative management. Medtronic Interstim system will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For cohort:
- For randomisation:
Key exclusion criteria (19 listed)
- For cohort
- For randomised control trial
- For TAI randomisation:
- For SNM randomisation:
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 |
|---|---|---|
| Sacral NeuroModulationSacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device. | Device | Sacral NeuroModulation |
| Trans-Anal IrrigationTrans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference. | Device | Trans-Anal Irrigation |
| Optimised Conservative ManagementOptimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently. | Other | Optimised Conservative Management, Sacral NeuroModulation, Trans-Anal Irrigation |
Primary outcome
Recruitment rate of to cohort arm of study
Time frame: 9 months
The total number of participants enrolled into the study over the recruitment period.
Assess characteristics of patients recruited to the cohort
Time frame: 9 months
We will record basic demographics, medical history and prevalence of relative symptoms of participants enrolled in the cohort study to describe the characteristics of no- minor- and major- LARS patients
Prevalence of 'major LARS' in the patient cohort
Time frame: 12 months
The number of participants in the cohort that meet the criteria for 'major low anterior resection syndrome (LARS)', as measured by the LARS scoring tool. LARS scoring tool produces a score from 0 - 42, which represents the severity of symptoms, where 0 is least severe and 42 is most severe. Score =>30 is considered 'major LARS'. LARS score will be measured at 5 times at 3-monthly intervals over 12 months.
Onset of 'major LARS' symptoms in relation to surgery
Time frame: Time from surgery to onset of major LARS, up to 10 years.
The time (in months) from resection surgery to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.
Onset of 'major LARS' symptoms in relation to radiotherapy treatment
Time frame: Time from ending radiotherapy treatment to onset of major LARS, up to 10 years.
The time (in months) from completing radiotherapy treatment to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.
Recruitment rate to randomised trial part of the study
Time frame: 9 months
The total number of cohort participants that are enrolled into the randomised trial part of the study, over the recruitment period.
Proportion of randomised participants that are allocated to each trial arm
Time frame: 9 months
The proportion of randomised participants that meet the criteria for, and are allocated to, each of the three trial arms (transanal irrigation; sacral neuromodulation; optimised conservative management).
Describe variation in clinical practice across UK sites
Time frame: Up to 10 years prior to recruitment
Where possible, we will record patient's previous treatments and interactions with health services in relation to their bowel dysfunction symptoms. This will be used to describe the variation in UK clinical practice in terms of diagnosis, management and treatment pathways.
Compliance of participants to the study programme
Time frame: 12 months
The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).
Adherence of participants to the treatment programme
Time frame: 12 months
The proportion of patients that continue to receive the treatment assigned to them at the end of the follow-up period.
7 secondary outcomes
Change in LARS score
Time frame: 12 months.
Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)
Time frame: 12 months
Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire
Time frame: 12 months
Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire
Time frame: 12 months
Change in medical outcome profile score
Time frame: 12 months
Patient-reported adverse events
Time frame: 12 months
LARS treatment history
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
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.
Julie A Cornish principal investigator
Cardiff and Vale University Health Board
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral NeuroModulation, Trans-Anal Irrigation and Optimised Conservative Management in people with Low Anterior Resection Syndrome, run by Cardiff and Vale University Health Board at 4 sites in United Kingdom.
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 13 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
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?
Recruitment rate of to cohort arm of study (time frame: 9 months). The study lists 10 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 20 Jul 2023.