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Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Study acronym: HYDROPTIC
StatusRecruiting
PhaseNot applicable
Started2022-03-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 5, 2026 (before its estimated March 9, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-12-30
minor
Study Status, Contacts/Locations v5
Primary completion date2027-01-15→2026-03-09
Completion date2027-03-15→2026-12-07
Study sitesdetails revised at 1 of 1 site
2023-07-10
minor
Study Status v4
Re-verified, no change to tracked fields
2022-07-26
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-02-15→confirmed 2022-03-02
2022-02-01
minor
Study Status v2
Primary completion date2026-12-20→2027-01-15
Completion date2027-02-20→2027-03-15
Start date2021-12-20→2022-02-15
2021-11-26
minor
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions v1
Start date2021-09-20→2021-12-20
Interventionsvenous sinus stenting /neurosurgical internal ventricular shunt on papillary edema (Procedure)→Neurosurgical internal ventricular shunt (Procedure), venous sinus stenting (Procedure)
Study title-30 characters
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension: a Randomized Controlled Trial.
2021-09-10
minor
Original filing
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses and whose origin remains unknown. This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the visual field and progress to blindness. Along with weight reduction, acetazolamide, which reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line treatment. Its efficacy is inconsistent in resolving papillary edema and there are many side effects. In the event of ineffectiveness or dependence on acetazolamide associated with hygiene and dietetic rules, a second line of therapy is then considered: neurosurgical (internal shunt of the LCS) or endovascular (venous stenting) treatment. These invasive techniques have each proven their effectiveness in the rapid and permanent resorption of OP, allowing improvement or preservation of visual function. In terms of induced morbidity, the superiority of one technique over the other, if it exists, has not been established. Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus venous sinus stenting in HTICi with moderate to severe visual impairment after failure of medical treatment defined by the absence of resorption of the OP after several months
Trial Details
NCT Number NCT05050864
Lead Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Conditions Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
Enrollment 276 participants
Start Date 2022-03-02
Primary Completion 2026-03-09 (estimated)
Study Completion 2026-12-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-05