Idiopathic Intracranial HypertensionIIH:WTNCT02124486
An RCT of Bariatric Surgery vs a Community Weight Loss Programme for the Sustained Treatment of IIH
A study testing Bariatric surgery and Dietetic intervention in people with Idiopathic Intracranial Hypertension, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes. The condition is associated with raised pressure in the brain and can cause disabling daily headaches and loss of sight, which can be permanent. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- Bariatric surgery and Dietetic intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2014to 2 Aug 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female IIH patients aged between 18 and 55 years, diagnosed according to the modified Dandy criteria who have chronic (> 6 months duration), active disease (papilloedema [Frisen grade ≥ 1], significantly raised ICP > 25cmH2O) and no evidence of venous sinus thrombosis (magnetic resonance or CT imaging and venography as noted at diagnosis).
- BMI >35kg/m2.
- Tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months.
- Able to give informed consent.
Who cannot join
- Age less than 18 or older than 55 years.
- Pregnant or planning to conceive during the first 18 months of the trial .
- Significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
- Undergone optic nerve sheath fenestration.
- Definite indication for or contraindication against surgery or dieting.
- Have a specific medical or psychiatric contraindication for surgery, including drug misuse, eating disorder or major depression (suicidal ideation, drug overdose or psychological admission in last 12 months).
Show all 9Show fewer
- Previous bariatric surgery.
- Taken AZD4017 within the last four months .
- Inability to give informed consent e.g. due to cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Birmingham (Queen Elizabeth Hospital)
Birmingham, West Midlands, B15 2TH
About this study
Official title: A Randomised Controlled Trial of Bariatric Surgery Versus a Community Weight Loss Programme for the Sustained Treatment of Idiopathic Intracranial Hypertension: the IIH:WT Trial
Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes. The condition is associated with raised pressure in the brain and can cause disabling daily headaches and loss of sight, which can be permanent. The raised brain pressure squashes the nerves supplying the eye (also known as papilloedema) and this can affect vision. Over 90% of patients with IIH are overweight and weight loss is the most effective treatment. Other treatments for IIH have very little current evidence to support their use.
Weight loss is difficult to maintain. This trial aims to compare two methods of weight loss, bariatric surgery and the most effective dietary programme commonly available, Weight Watchers, to see which offers the most effective sustainable treatment for IIH. Bariatric surgery is recommended by the NICE clinical guidelines for patients with a Body Mass Index (BMI) of over 40, or over 35 with a co-morbidity. Women suffering from IIH have a BMI on average around 38 and IIH is not recognised as a co-morbidity for bariatric surgery.
Read more
This trial will recruit 64 women with IIH from Neurology and Ophthalmology clinics in UK NHS Trusts. They will be randomised and 32 participants will be allocated to the dietetic intervention arm, and be enrolled in their local Weight Watchers group. 32 participants will be allocated to the bariatric surgery arm, and will be referred to their local bariatric surgery pathway to receive bariatric surgery. Both groups of participants will be allocated to a treatment arm which is proven to bring about weight loss.
Participants will then be followed up for five years, with the most important measurement being their brain pressure after one year of being in the trial.
A further 20 obese women who don't suffer from IIH will be recruited to compare the baseline symptoms and biomarkers of those with IIH; they will take no further part in the study. 5 further healthy individuals will be scanned twice in an MRI test group to validate the MRI scan sequence to be used in the trial.
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- Bariatric surgery, Dietetic intervention
- Keywords
- IIH, Weight loss, Bariatric surgery
- Medical subject headings
- Pseudotumor Cerebri, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Participants randomised to the bariatric surgery arm of the trial will be referred to the surgery pathway according to NICE guidelines at Birmingham Heartlands Hospital (BHH), Heart of England NHS Foundation Trust.
Dietetic interventionBehavioural
Also called Weight Watchers
Participants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers.
| Study group | Role | What they receive |
|---|---|---|
| Dietetic Intervention | Active comparator | Participants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers diet programme. Receives: Behavioral: Dietetic intervention |
| Bariatric surgery | Experimental | Patients randomised to the bariatric surgery arm will be referred to the bariatric surgery pathway and, if judged suitable according to the bariatric surgery clinic's screening processes, undergo bariatric surgery. Receives: Procedure: Bariatric surgery |
| Matched obese control group | No intervention | To evaluate the baseline difference in ICP between IIH patients and a matched obese control cohort we will recruit 20 obese but otherwise healthy participants who will undergo the same baseline visit as the main trial participants and then exit the study. |
| MRI Test run | No intervention | 5 patients will undergo double baseline MR scans to validate the novel MR sequences being used in the main trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Pressure
Change in Intracranial Pressure (ICP) between baseline and 12 months.
ICP will be assessed using lumbar puncture (LP). To avoid the LP affecting the visual measures it will be performed after the visual tests have been completed. ICP will be recorded to the nearest whole number in cmH2O. Both opening and closing ICP will be recorded.
Measured: 12 months
Secondary outcomes (9)
Intracranial Pressure
Change in ICP between baseline and 24 and 60 months.
ICP will be assessed using lumbar puncture (LP). To avoid the LP affecting the visual measures it will be performed after the visual tests have been completed. ICP will be recorded to the nearest whole number in cmH2O. Both opening and closing ICP will be recorded.
Measured: 60 months
IIH symptoms
Change in reported IIH symptoms from 0 to 12 months (and at 3, 6, 24 and 60 months)
Measured: 12 months
Visual function
Change in visual function from 0 to 12 months (and at 24 and 60 months).
Assessments to be undertaken are the LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation, an evaluation of contrast sensitivity and an Ishihara book to assess colour vision. The pupils will then be dilated using 1% tropicamide. Papilloedema will then be measured using spectral optical coherence tomography. Papilloedema will be further graded following fundus photographs. This will be done after all participants have reached the primary endpoint by two neuro-ophthalmologists blinded to trial treatment arm. The assessors will score the paired papilloedema images as better/same/worse as per the methodology described in a previous study. They will also assign a Frisen score to the images.
Measured: 12 months
Papilloedema
Change in papilloedema from 0 to 12 months (and at 24 and 60 months)
Measured: 12 months
Headache
Change in headache associated disability from 0 to 12 months (and at 24 and 60 months).
Headache will be assessed by participant completed questionnaires. Participants will complete a daily headache diary in the week before assessments, which will evaluate the Headache Index score and use of analgesia (days/week). Headache associated disability will be evaluated using the Headache Impact Test-6 score (HIT 6). Severity and frequency of headaches will be assessed retrospectively using the Headache Index. Headache phenotype (according to criteria from the International Headache Society) will also be assessed.
Measured: 12 months
Anthropometric measures
Change in anthropometric measures (e.g. waist, hip, fat mass) from 0 to 12 months (and at 24 and 60 months)
Measured: 12 months
Quality of Life (EQ-5D-5L and SF-36)
Change in quality of life (participant reported) from 0 to 12 months (and at 24 and 60 months)
Measured: 12 months
Referrals to CSF shunting procedures and optic nerve sheath fenestration
Difference in number of referrals to cerebrospinal fluid (CSF) shunting procedures and optic nerve sheath fenestration between treatment arms at 0 to 12 months (and at 24 and 60 months)
Measured: 12 months
Health Economics
Health economics including cost-effectiveness at 12, 24 and 60 months.
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 posted28 Apr 2014 (estimated)
- Study start6 Mar 2014
- Primary completion2 Aug 2018
- Study completion2 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Intracranial HypertensionStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Dr Alexandra Sinclair, University of Birmingham
- Investigators
- Alexandra Sinclair, MBChB, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124486
- Sponsor's protocol ID
- RG_12-089
- Other IDs
- CS-011-028, 14/WM/0011, ISRCTN40152829
- Acronym
- IIH:WT
- Status last verified
- Nov 2020
- First submitted
- 22 Apr 2014
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grech O, Seneviratne SY, Alimajstorovic Z, Yiangou A, Mitchell JL, Smith TB, Mollan SP, Lavery GG, Ludwig C, Sinclair AJ. Nuclear Magnetic Resonance Spectroscopy Metabolomics in Idiopathic Intracranial Hypertension to Identify Markers of Disease and Headache. Neurology. 2022 Oct 17;99(16):e1702-e1714. doi: 10.1212/WNL.0000000000201007.
PubMed 36240084Mollan SP, Mitchell JL, Yiangou A, Ottridge RS, Alimajstorovic Z, Cartwright DM, Hickman SJ, Markey KA, Singhal R, Tahrani AA, Frew E, Brock K, Sinclair AJ. Association of Amount of Weight Lost After Bariatric Surgery With Intracranial Pressure in Women With Idiopathic Intracranial Hypertension. Neurology. 2022 Sep 13;99(11):e1090-e1099. doi: 10.1212/WNL.0000000000200839. Epub 2022 Jul 5.
PubMed 35790425Mollan SP, Wakerley BR, Alimajstorovic Z, Mitchell J, Ottridge R, Yiangou A, Thaller M, Gupta A, Grech O, Lavery G, Brock K, Sinclair AJ. Intracranial pressure directly predicts headache morbidity in idiopathic intracranial hypertension. J Headache Pain. 2021 Oct 7;22(1):118. doi: 10.1186/s10194-021-01321-8.
PubMed 34620087Yiangou A, Mitchell JL, Nicholls M, Chong YJ, Vijay V, Wakerley BR, Lavery GG, Tahrani AA, Mollan SP, Sinclair AJ. Obstructive sleep apnoea in women with idiopathic intracranial hypertension: a sub-study of the idiopathic intracranial hypertension weight randomised controlled trial (IIH: WT). J Neurol. 2022 Apr;269(4):1945-1956. doi: 10.1007/s00415-021-10700-9. Epub 2021 Aug 22.
PubMed 34420064Mollan SP, Mitchell JL, Ottridge RS, Aguiar M, Yiangou A, Alimajstorovic Z, Cartwright DM, Grech O, Lavery GG, Westgate CSJ, Vijay V, Scotton W, Wakerley BR, Matthews TD, Ansons A, Hickman SJ, Benzimra J, Rick C, Singhal R, Tahrani AA, Brock K, Frew E, Sinclair AJ. Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):678-686. doi: 10.1001/jamaneurol.2021.0659.
PubMed 33900360Ottridge R, Mollan SP, Botfield H, Frew E, Ives NJ, Matthews T, Mitchell J, Rick C, Singhal R, Woolley R, Sinclair AJ. Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol. BMJ Open. 2017 Sep 27;7(9):e017426. doi: 10.1136/bmjopen-2017-017426.
PubMed 28963303
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Bariatric Surgery Versus a Community Weight Loss Programme for the Sustained Treatment of Idiopathic Intracranial Hypertension: the IIH:WT Trial
- ClinicalTrials.gov ID
- NCT02124486
- Acronym / sponsor ID
- IIH:WT / RG_12-089
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- IIH, Weight loss, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2022 (estimated)
- First posted
- 28 Apr 2014 (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.
Idiopathic intracranial hypertension (IIH) is a condition with an unknown cause or causes. The condition is associated with raised pressure in the brain and can cause disabling daily headaches and loss of sight, which can be permanent. The raised brain pressure squashes the nerves supplying the eye (also known as papilloedema) and this can affect vision. Over 90% of patients with IIH are overweight and weight loss is the most effective treatment. Other treatments for IIH have very little current evidence to support their use.
Weight loss is difficult to maintain. This trial aims to compare two methods of weight loss, bariatric surgery and the most effective dietary programme commonly available, Weight Watchers, to see which offers the most effective sustainable treatment for IIH. Bariatric surgery is recommended by the NICE clinical guidelines for patients with a Body Mass Index (BMI) of over 40, or over 35 with a co-morbidity. Women suffering from IIH have a BMI on average around 38 and IIH is not recognised as a co-morbidity for bariatric surgery.
This trial will recruit 64 women with IIH from Neurology and Ophthalmology clinics in UK NHS Trusts. They will be randomised and 32 participants will be allocated to the dietetic intervention arm, and be enrolled in their local Weight Watchers group. 32 participants will be allocated to the bariatric surgery arm, and will be referred to their local bariatric surgery pathway to receive bariatric surgery. Both groups of participants will be allocated to a treatment arm which is proven to bring about weight loss.
Participants will then be followed up for five years, with the most important measurement being their brain pressure after one year of being in the trial.
A further 20 obese women who don't suffer from IIH will be recruited to compare the baseline symptoms and biomarkers of those with IIH; they will take no further part in the study. 5 further healthy individuals will be scanned twice in an MRI test group to validate the MRI scan sequence to be used in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietetic Intervention | Active comparator | Behavioral: Dietetic interventionParticipants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers diet programme. |
| Bariatric surgery | Experimental | Procedure: Bariatric surgeryPatients randomised to the bariatric surgery arm will be referred to the bariatric surgery pathway and, if judged suitable according to the bariatric surgery clinic's screening processes, undergo bariatric surgery. |
| Matched obese control group | No intervention | –To evaluate the baseline difference in ICP between IIH patients and a matched obese control cohort we will recruit 20 obese but otherwise healthy participants who will undergo the same baseline visit as the main trial participants and then exit the study. |
| MRI Test run | No intervention | –5 patients will undergo double baseline MR scans to validate the novel MR sequences being used in the main trial. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female IIH patients aged between 18 and 55 years, diagnosed according to the modified Dandy criteria who have chronic (> 6 months duration), active disease (papilloedema [Frisen grade ≥ 1], significantly raised ICP > 25cmH2O) and no evidence of venous sinus thrombosis (magnetic resonance or CT imaging and venography as noted at diagnosis).
- BMI >35kg/m2.
- Tried other appropriate non-surgical treatments to lose weight but have not been able to achieve or maintain adequate, clinically beneficial weight loss for at least 6 months.
- Able to give informed consent.
Key exclusion criteria (9 listed)
- Age less than 18 or older than 55 years.
- Pregnant or planning to conceive during the first 18 months of the trial .
- Significant co-morbidity, endocrinopathy or the use of hormone manipulating medication (excluding contraception and topical or inhaled steroids).
- Undergone optic nerve sheath fenestration.
- Definite indication for or contraindication against surgery or dieting.
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 |
|---|---|---|
| Bariatric surgeryParticipants randomised to the bariatric surgery arm of the trial will be referred to the surgery pathway according to NICE guidelines at Birmingham Heartlands Hospital (BHH), Heart of England NHS Foundation Trust. | Procedure or surgery | Bariatric surgery |
| Dietetic interventionAlso: Weight WatchersParticipants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers. | Behavioural | Dietetic Intervention |
Primary outcome
Intracranial Pressure
Time frame: 12 months
Change in Intracranial Pressure (ICP) between baseline and 12 months. ICP will be assessed using lumbar puncture (LP). To avoid the LP affecting the visual measures it will be performed after the visual tests have been completed. ICP will be recorded to the nearest whole number in cmH2O. Both opening and closing ICP will be recorded.
9 secondary outcomes
Intracranial Pressure
Time frame: 60 months
IIH symptoms
Time frame: 12 months
Visual function
Time frame: 12 months
Papilloedema
Time frame: 12 months
Headache
Time frame: 12 months
Anthropometric measures
Time frame: 12 months
Quality of Life (EQ-5D-5L and SF-36)
Time frame: 12 months
Referrals to CSF shunting procedures and optic nerve sheath fenestration
Time frame: 12 months
Health Economics
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 5 Nov 2020.
- Derived from this study: PubMed 36240084Grech O, Seneviratne SY, Alimajstorovic Z, Yiangou A, Mitchell JL, Smith TB, Mollan SP, Lavery GG, Ludwig C, Sinclair AJ. Nuclear Magnetic Resonance Spectroscopy Metabolomics in Idiopathic Intracranial Hypertension to Identify Markers of Disease and Headache. Neurology. 2022 Oct 17;99(16):e1702-e1714. doi: 10.1212/WNL.0000000000201007.
- Derived from this study: PubMed 35790425Mollan SP, Mitchell JL, Yiangou A, Ottridge RS, Alimajstorovic Z, Cartwright DM, Hickman SJ, Markey KA, Singhal R, Tahrani AA, Frew E, Brock K, Sinclair AJ. Association of Amount of Weight Lost After Bariatric Surgery With Intracranial Pressure in Women With Idiopathic Intracranial Hypertension. Neurology. 2022 Sep 13;99(11):e1090-e1099. doi: 10.1212/WNL.0000000000200839. Epub 2022 Jul 5.
- Derived from this study: PubMed 34620087Mollan SP, Wakerley BR, Alimajstorovic Z, Mitchell J, Ottridge R, Yiangou A, Thaller M, Gupta A, Grech O, Lavery G, Brock K, Sinclair AJ. Intracranial pressure directly predicts headache morbidity in idiopathic intracranial hypertension. J Headache Pain. 2021 Oct 7;22(1):118. doi: 10.1186/s10194-021-01321-8.
- Derived from this study: PubMed 34420064Yiangou A, Mitchell JL, Nicholls M, Chong YJ, Vijay V, Wakerley BR, Lavery GG, Tahrani AA, Mollan SP, Sinclair AJ. Obstructive sleep apnoea in women with idiopathic intracranial hypertension: a sub-study of the idiopathic intracranial hypertension weight randomised controlled trial (IIH: WT). J Neurol. 2022 Apr;269(4):1945-1956. doi: 10.1007/s00415-021-10700-9. Epub 2021 Aug 22.
- Derived from this study: PubMed 33900360Mollan SP, Mitchell JL, Ottridge RS, Aguiar M, Yiangou A, Alimajstorovic Z, Cartwright DM, Grech O, Lavery GG, Westgate CSJ, Vijay V, Scotton W, Wakerley BR, Matthews TD, Ansons A, Hickman SJ, Benzimra J, Rick C, Singhal R, Tahrani AA, Brock K, Frew E, Sinclair AJ. Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):678-686. doi: 10.1001/jamaneurol.2021.0659.
- Derived from this study: PubMed 28963303Ottridge R, Mollan SP, Botfield H, Frew E, Ives NJ, Matthews T, Mitchell J, Rick C, Singhal R, Woolley R, Sinclair AJ. Randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of idiopathic intracranial hypertension: the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT) protocol. BMJ Open. 2017 Sep 27;7(9):e017426. doi: 10.1136/bmjopen-2017-017426.
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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.
Alexandra Sinclair, MBChB principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery and Dietetic intervention in people with Idiopathic Intracranial Hypertension, run by University of Birmingham at 1 site 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 4 inclusion and 9 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 5 Nov 2020. 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 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?
Intracranial Pressure (time frame: 12 months). 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 NCT02124486, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.