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NCT03028246 · ClinicalTrials.gov registry record · NA

A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

A NA study of Benign Centrally-Located Intracranial Tumors, sponsored by InSightec.

Recruiting
Registry status
NA
Development phase
20
Enrollment target
2
Study locations

NCT03028246: Recruiting NA study of Benign Centrally-Located Intracranial Tumors, sponsored by InSightec.

NCT03028246 is a NA study of Benign Centrally-Located Intracranial Tumors that is actively recruiting participants, run by InSightec. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03028246, a NA study of Benign Centrally-Located Intracranial Tumors, is actively recruiting participants, sponsored by InSightec.

RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible.

Primary Outcome

Safety will be assessed by tabulation of treatment related adverse events. All adverse events at least possibly procedure related will also be examined in detail for patterns of occurrence.

Interventions

  • DEVICE ExAblate 4000 System

Study Locations (2)

District of Columbia

  • Children's National Medical Center - Washington D.C.

Florida

  • Nicklaus Children's Hospital - Miami

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-02-28
Est. Completion 2026-12-31
Phase NA
InSightec

38 total trials

What NCT03028246 shows while recruiting

NCT03028246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Benign Centrally-Located Intracranial Tumors appearing as the primary indexed condition, and to 1 intervention - of which ExAblate 4000 System is the first listed.

NCT03028246 reports a single indexed study location in District of Columbia, Florida.

Frequently Asked Questions

What is clinical trial NCT03028246 about?

NCT03028246 is a clinical study titled "A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects". The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of be...

What is the current status of trial NCT03028246?

This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2017-02-28. Estimated completion is 2026-12-31.

What conditions does trial NCT03028246 study?

This clinical trial studies the following conditions: Benign Centrally-Located Intracranial Tumors.

What interventions are being tested in trial NCT03028246?

The interventions under investigation include: ExAblate 4000 System (DEVICE).

Who is sponsoring clinical trial NCT03028246?

This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03028246 being conducted?

This trial has 2 study locations across District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03028246's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03028246, the US trial registry maintained by the National Library of Medicine. NCT03028246 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.