Olfaction DisordersPhase 2NCT01814618
Trial of Directed High-dose Nasal Steroids on Residual Smell Loss in Sinus Patients After Sinus Surgery
A Phase 2 study testing Budesonide Respules in people with Olfaction Disorders and Sinusitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Olfaction Disorders, Sinusitis, Paranasal Sinus Diseases
- What is being tested?
- Budesonide Respules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2013
- Phase
- Phase 2
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are otherwise healthy undergoing surgery for treatment of chronic rhinosinusitis will be evaluated for olfactory dysfunction, and if present, will be recruited for study participation. The subjects will be included without regard to their gender, race or ethnicity. Subjects will be identified from patients in the clinical practices of the Department of Otolaryngology - Head and Neck Surgery at the University of North Carolina. Only adult patients greater than 18 years old and less than 85 will be approached for this study, as patient treatment algorithms outside this range tend to vary with greater frequency. Due to limited resources, only patients fluent in English will be included, thus minimizing confounding variables and hurdles to patient communication, as some clinics do not have interpreting services. Also, most of the quality of life surveys and olfactory testing do not have non English versions. Only patients with health insurance will be included in the study in order to ensure all participants have access to the study drug.
Who cannot join
- If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding. If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study because of the need for repeat CTs and the possible systemic manifestations due to steroid irrigation. Further exclusion criteria will include the following: hypersensitivity to cortisol, history of pituitary disease, and allergic disease with subsequent anaphylaxis or breathing difficulties. Additionally, patients with a history of immunodeficiency, autoimmune disease, cystic fibrosis, or previous sinus surgery will be excluded as these co-morbidities might cloud the relationship between the treatment and the outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill Department of Otolaryngology/Head and Neck Surgery
Chapel Hill, North Carolina, 27514
About this study
Official title: Trial of Directed High-dose Nasal Steroids on Residual Olfactory Dysfunction in Patients With Chronic Rhinosinusitis Following Endoscopic Sinus Surgery
The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Other outcomes of this study include: identifying the differences in sinus airflow between patients who improve following nasal steroid treatment and those who do not, and to see if, in patients who improve following surgery, the improvement remains throughout follow-up.
Read the detailed description
OVERVIEW:
This is a prospective randomized cohort study assessing the use of directed high-dose nasal steroids for improving olfactory function after endoscopic sinus surgery for chronic rhinosinusitis. Up to 70 subjects will be prospectively enrolled from patients visiting the Department of Otolaryngology-Head and Neck Surgery clinics at the University of North Carolina (UNC) Hospitals.
VISIT 1/PRE-OPERATIVE VISIT
Visit 1 will be the day of enrollment or the pre-operative visit. During this encounter, subjects will complete the Rhinosinusitis Disability Index (RSDI), Rhinosinusitis Outcome Measure 31 (RSOM-31), Sinonasal Outcome Test 22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), Phenyl-ethyl-alcohol (PEA) tests and will also have their Lund-Kennedy scores recorded. Additionally, all subjects will undergo a pre-operative (standard of care) head CT which will be scored with the Lund-Mackay system. This standard of care head CT will be billed to the subject's insurance.
VISIT 2/POST-OPERATIVE VISIT(POV) 1
Visit 2 will occur at "post-operative visit 1" or 4-6 weeks after surgery. During this encounter, subjects will complete the RSDI, RSOM-31, SNOT-22, UPSIT, PEA tests and will also have their Lund-Kennedy scores recorded. Additionally, all subjects will undergo post-operative (standard of care) head CT. This standard of care head CT will be billed to the subject's insurance. Subjects who do have quantitative improvement in olfaction (as determined by UPSIT category score) will be considered part of the "improved" group and will simply be followed without an intervention. Subjects who do not have quantitative improvement in olfaction will be randomized (with a random number generator) into a "treatment" or an "observation" group. Subjects within the treatment group will be given a 12-week course of directed high-dose nasal steroid irrigation. Pharmacies will bill the subjects' insurance for the medication. Subjects will be instructed to perform irrigation twice daily using ½ budesonide respule, 0.5 mg/2mL, applied directly to the nasal mucosa as described previously. Subjects will be given written instructions on how to perform nasal irrigation with this medication. Subjects randomized to receive medication will be given medication diaries and asked to document medication compliance and side effects.
PHONE INTERVIEW (1-2 WEEKS AFTER TREATMENT)
Subjects randomized to the treatment arm will be called 1-2 weeks after initiation of budesonide treatment to assess medication compliance and side effects. Subjects will be asked to review their medication diaries when answering questions about compliance and side effects. As detailed in the data safety monitoring plan, the PI will be alerted if any subjects are experiencing moderate-severe adverse events or any unexpected side effects.
VISIT 3/"SURVEILLANCE" VISIT
Visit 3 will be a surveillance visit somewhere between post-operative visit 1 (at 4-6 weeks) and post-operative visit 2 (at 3-4 months). Only patients in the treatment arm will have this visit. During this visit, subjects will be asked about medication compliance and asked to demonstrate irrigation technique with nasal saline. Medication diaries will be reviewed and assessed for compliance and concerning side effects. These diaries will be collected for future review by the independent data safety reviewer.
VISIT 4/ POST-OPERATIVE VISIT (POV) 2
Visit 4 will occur at post-operative visit 2 or 3-4 months after surgery. During this encounter, subjects will complete the RSDI, RSOM-31, SNOT-22, UPSIT, PEA tests and will also have their Lund-Kennedy scores recorded. Subjects in the "non-improved" arm (regardless of whether they were randomized to receive nasal steroids) will have an additional (for research purposes only) head CT. This research only head CT will be provided free of charge by the Department of Otolaryngology's CT scanner.
Medication diaries will be reviewed and assessed for compliance and concerning side effects. These diaries will be collected for future review by the independent data safety reviewer.
- Conditions
- Olfaction Disorders, Sinusitis, Paranasal Sinus Diseases
- Being tested
- Budesonide Respules
- Medical subject headings
- Olfaction Disorders, Sinusitis, Paranasal Sinus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide RespulesDrug
Also called Pulmicort respules
Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | These subjects did not have improved sense of smell after surgery and were randomized to this observation group or treatment group. These patients will be observed post-operatively but will not receive the trial medication. |
| Treatment | Experimental | These subjects did not have improved sense of smell after surgery and were randomized to this treatment group or the observation. These patients will be observed post-operatively and will receive a 3-month course of topical nasal steroids(budesonide respules).
Drug: Budesonide Respules
Other Names:
Pulmicort respules
Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months. Receives: Drug: Budesonide Respules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Degree of Olfactory Function
Measurements of smell will be taken at the initial preoperative visit and again at the 4-6 week postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.
Measured: 4-6 week post-operative visit
Change in Degree of Olfactory Function
Measurements of smell will be taken at the initial preoperative visit and again at the 3-4 month postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.
Measured: 3-4 month post-operative visit
Secondary outcomes (8)
Change in Head CT Grade
A head CT will be performed at the initial preoperative visit and at the 4-6 week post-operative visit. The head CT will be assessed using the Lund-Mackay scoring system, in which physician graders will analyze the CT for abnormalities in the patient's sinuses and nasal cavity.
Measured: 4-6 week post-operative visit
Change in Head CT Grade
Subjects in the "non-improved" arm (regardless of whether they were randomized to receive nasal steroids) will receive a head CT at this time point. The CT will be assessed using the Lund-Mackay scoring system, in which physician graders will analyze the CT for abnormalities in the patient's sinuses and nasal cavity.
Measured: 3-4 month post-operative visit
Change in Nasal Endoscopy Grade
Nasal endoscopy will be performed at the initial preoperative visit and again at the 4-6 week postoperative visit. The nasal cavity and sinuses will be assessed using the Lund-Kennedy scoring method which addresses crusting, scarring, edema, discharge, and presence of polyps.
Measured: 4-6 week post-operative visit
Change in Nasal Endoscopy Grade
Nasal endoscopy will be performed at the initial preoperative visit and at the 3-4 month postoperative visit. The nasal cavity and sinuses will be assessed using the Lund-Kennedy scoring method which addresses crusting, scarring, edema, discharge, and presence of polyps.
Measured: 3-4 month post-operative visit
Change in Quality of Life
Quality of life will be assessed at the initial preoperative visit as well as the 4-6 week postoperative visit using the Sinonasal Outcome Test 22(SNOT-22) and the Rhinosinusitis Outcome Measure 31 (RSOM-31). The Snot-22 and RSOM-31 are questionnaires used to measure disease related quality of life and symptoms.
Measured: 4-6 week post-operative visit
Change in Quality of Life
Quality of life will be assessed at the initial preoperative visit as well as the 3-4 month postoperative visit using the Sinonasal Outcome Test 22(SNOT-22) and the Rhinosinusitis Outcome Measure 31 (RSOM-31). The Snot-22 and RSOM-31 are questionnaires used to measure disease related quality of life and symptoms.
Measured: 3-4 month post-operative visit
Number of patients with steroid side effects after a 1-2 week course of steroids
Subjects who were randomized to the treatment arm will be contacted by phone 1-2 weeks after starting steroids and will review a pre-constructed medication safety and side effect questionnaire with the caller. Patients will also be asked to review their medication diary with the caller.
Measured: 5-8 weeks post-operatively
Number of patients with steroid side effects after a 8 week course of steroids
Subjects who were randomized to the treatment arm will return to clinic 3-4 months postoperatively and medication diaries will be reviewed and assessed for compliance and concerning side effects. These diaries will be collected for future review by the independent data safety reviewer.
Measured: 3-4 month post-operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam M Zanation, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814618
- Sponsor's protocol ID
- 12-1567
- Status last verified
- Sep 2014
- First submitted
- 18 Mar 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Directed High-dose Nasal Steroids on Residual Olfactory Dysfunction in Patients With Chronic Rhinosinusitis Following Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT01814618
- Acronym / sponsor ID
- 12-1567
- Conditions
- Olfaction Disorders, Sinusitis, Paranasal Sinus Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- 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.
The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Other outcomes of this study include: identifying the differences in sinus airflow between patients who improve following nasal steroid treatment and those who do not, and to see if, in patients who improve following surgery, the improvement remains throughout follow-up.
Detailed description
OVERVIEW:
This is a prospective randomized cohort study assessing the use of directed high-dose nasal steroids for improving olfactory function after endoscopic sinus surgery for chronic rhinosinusitis. Up to 70 subjects will be prospectively enrolled from patients visiting the Department of Otolaryngology-Head and Neck Surgery clinics at the University of North Carolina (UNC) Hospitals.
VISIT 1/PRE-OPERATIVE VISIT
Visit 1 will be the day of enrollment or the pre-operative visit. During this encounter, subjects will complete the Rhinosinusitis Disability Index (RSDI), Rhinosinusitis Outcome Measure 31 (RSOM-31), Sinonasal Outcome Test 22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), Phenyl-ethyl-alcohol (PEA) tests and will also have their Lund-Kennedy scores recorded. Additionally, all subjects will undergo a pre-operative (standard of care) head CT which will be scored with the Lund-Mackay system. This standard of care head CT will be billed to the subject's insurance.
VISIT 2/POST-OPERATIVE VISIT(POV) 1
Visit 2 will occur at "post-operative visit 1" or 4-6 weeks after surgery. During this encounter, subjects will complete the RSDI, RSOM-31, SNOT-22, UPSIT, PEA tests and will also have their Lund-Kennedy scores recorded. Additionally, all subjects will undergo post-operative (standard of care) head CT. This standard of care head CT will be billed to the subject's insurance. Subjects who do have quantitative improvement in olfaction (as determined by UPSIT category score) will be considered part of the "improved" group and will simply be followed without an intervention. Subjects who do not have quantitative improvement in olfaction will be randomized (with a random number generator) into a "treatment" or an "observation" group. Subjects within the treatment group will be given a 12-week course of directed high-dose nasal steroid irrigation. Pharmacies will bill the subjects' insurance for the medication. Subjects will be instructed to perform irrigation twice daily using ½ budesonide respule, 0.5 mg/2mL, applied directly to the nasal mucosa as described previously. Subjects will be given written instructions on how to perform nasal irrigation with this medication. Subjects randomized to receive medication will be given medication diaries and asked to document medication compliance and side effects.
PHONE INTERVIEW (1-2 WEEKS AFTER TREATMENT)
Subjects randomized to the treatment arm will be called 1-2 weeks after initiation of budesonide treatment to assess medication compliance and side effects. Subjects will be asked to review their medication diaries when answering questions about compliance and side effects. As detailed in the data safety monitoring plan, the PI will be alerted if any subjects are experiencing moderate-severe adverse events or any unexpected side effects.
VISIT 3/"SURVEILLANCE" VISIT
Visit 3 will be a surveillance visit somewhere between post-operative visit 1 (at 4-6 weeks) and post-operative visit 2 (at 3-4 months). Only patients in the treatment arm will have this visit. During this visit, subjects will be asked about medication compliance and asked to demonstrate irrigation technique with nasal saline. Medication diaries will be reviewed and assessed for compliance and concerning side effects. These diaries will be collected for future review by the independent data safety reviewer.
VISIT 4/ POST-OPERATIVE VISIT (POV) 2
Visit 4 will occur at post-operative visit 2 or 3-4 months after surgery. During this encounter, subjects will complete the RSDI, RSOM-31, SNOT-22, UPSIT, PEA tests and will also have their Lund-Kennedy scores recorded. Subjects in the "non-improved" arm (regardless of whether they were randomized to receive nasal steroids) will have an additional (for research purposes only) head CT. This research only head CT will be provided free of charge by the Department of Otolaryngology's CT scanner.
Medication diaries will be reviewed and assessed for compliance and concerning side effects. These diaries will be collected for future review by the independent data safety reviewer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –These subjects did not have improved sense of smell after surgery and were randomized to this observation group or treatment group. These patients will be observed post-operatively but will not receive the trial medication. |
| Treatment | Experimental | Drug: Budesonide RespulesThese subjects did not have improved sense of smell after surgery and were randomized to this treatment group or the observation. These patients will be observed post-operatively and will receive a 3-month course of topical nasal steroids(budesonide respules). Drug: Budesonide Respules Other Names: Pulmicort respules Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are otherwise healthy undergoing surgery for treatment of chronic rhinosinusitis will be evaluated for olfactory dysfunction, and if present, will be recruited for study participation. The subjects will be included without regard to their gender, race or ethnicity. Subjects will be identified from patients in the clinical practices of the Department of Otolaryngology - Head and Neck Surgery at the University of North Carolina. Only adult patients greater than 18 years old and less than 85 will be approached for this study, as patient treatment algorithms outside this range tend to vary with greater frequency. Due to limited resources, only patients fluent in English will be included, thus minimizing confounding variables and hurdles to patient communication, as some clinics do not have interpreting services. Also, most of the quality of life surveys and olfactory testing do not have non English versions. Only patients with health insurance will be included in the study in order to ensure all participants have access to the study drug.
Key exclusion criteria (1 listed)
- If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding. If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study because of the need for repeat CTs and the possible systemic manifestations due to steroid irrigation. Further exclusion criteria will include the following: hypersensitivity to cortisol, history of pituitary disease, and allergic disease with subsequent anaphylaxis or breathing difficulties. Additionally, patients with a history of immunodeficiency, autoimmune disease, cystic fibrosis, or previous sinus surgery will be excluded as these co-morbidities might cloud the relationship between the treatment and the outcome.
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 |
|---|---|---|
| Budesonide RespulesAlso: Pulmicort respulesSubjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months. | Drug | Treatment |
Primary outcome
Change in Degree of Olfactory Function
Time frame: 4-6 week post-operative visit
Measurements of smell will be taken at the initial preoperative visit and again at the 4-6 week postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.
Change in Degree of Olfactory Function
Time frame: 3-4 month post-operative visit
Measurements of smell will be taken at the initial preoperative visit and again at the 3-4 month postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.
8 secondary outcomes
Change in Head CT Grade
Time frame: 4-6 week post-operative visit
Change in Head CT Grade
Time frame: 3-4 month post-operative visit
Change in Nasal Endoscopy Grade
Time frame: 4-6 week post-operative visit
Change in Nasal Endoscopy Grade
Time frame: 3-4 month post-operative visit
Change in Quality of Life
Time frame: 4-6 week post-operative visit
Change in Quality of Life
Time frame: 3-4 month post-operative visit
Number of patients with steroid side effects after a 1-2 week course of steroids
Time frame: 5-8 weeks post-operatively
Number of patients with steroid side effects after a 8 week course of steroids
Time frame: 3-4 month post-operative visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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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.
Adam M Zanation, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide Respules in people with Olfaction Disorders and Sinusitis, run by University of North Carolina, Chapel Hill 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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Degree of Olfactory Function (time frame: 4-6 week post-operative visit). 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?
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 6 Apr 2016.