Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
This study is looking at a new way to get better images of the pituitary gland (a small gland at the base of your brain) during surgery for pituitary tumors. The intervention being tested is called an Endosphenoidal Coil (ESC). Researchers want to see if using the ESC is safe and practical as an additional tool during transsphenoidal surgery (a type of surgery to remove pituitary tumors through the nose). This study is for adults aged 18 to 85 who have a known or suspected pituitary tumor requiring this type of surgery. The goal is to improve imaging, especially for very small tumors that are hard to see with standard MRI scans. The study is currently unclear on its recruitment status and plans to enroll 70 participants.
- Study design
- This is an interventional study with an unclear status, planning to enroll 70 participants. It is not specified if it's randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, safety and feasibility of the ESC, are measured at ongoing timeframes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of Endosphenoidal Coil Placement for Imaging of the Sella During Transsphenoidal Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Prashant Chittiboina, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)
Who to contact
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What this trial measures
- Safety of ESC as an Intraoperative Adjunct ToolOngoing
We hypothesize that using ESC is safe for patients undergoing TSS. We will monitor for adverse events that may arise due to the insertion, use and removal of the ESC. The surgical corridor will be monitored for bleeding, burns, physical trauma or impingement during insertion of ESC (by direct observation) and during imaging (via video feed), and after removal of the ESC (by direct observation). The adverse events will be graded as follows: Grade 0 uneventful deployment of the ESC; Grade I adverse events due to ESC deployment without any intra-operative consequences; Grade II adverse events due to ESC deployment needing surgical interventions (e.g. control of bleeding, modification of surgical approach, need for blood transfusion etc.) or burn injuries needing surgical management; Grade III severe adverse events due to ESC deployment needing immediate termination of the surgical procedure or permanent physical/neurologic injury due to impingement.
- Feasibility of ESC as a Clinical ToolOngoing
Clinical utility will be evaluated by a board certified neuroradiologist. The utility measure is a binary outcome measure (yes/no). The neuroradiologist will also make additional subjective observations about the image quality, image resolution, imaging artifacts and image noise. For patients with microadenomas, the primary outcome measure will be the accuracy of the ESC in detecting previously detected microadenomas. A positive outcome measure will be denoted if a possible microadenoma is detected with the ESC in the same location as detected by pre-operative MRI imaging. For patients with pituitary macroadenomas, the primary outcome will be detection of invasion of the cavernous sinus and ability to detect intra-tumoral heterogeneity. For patients with MRI negative pituitary disease, the primary outcome measure will be the ability to detect adenomas. At the conclusion of enrollment, all images will be reviewed by an independent board-certified neuroradiologist.