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SUSPENDED
NCT04222309
PHASE1

Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients. All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2020-01-06

Completion Date

2028-01-31

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopically harvested omental free flap

Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

Locations (1)

Lenox Hill Brain Tumor Center

New York, New York, United States