Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

Recruiting

• Conditions: Bone Cysts

• Registration Number: NCT05880628
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

Detailed Description

The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.

Study Timeline

• Study Start: 2022-04-14
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-05-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel

Exclusion Criteria

• Refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the technique	Year: 2	Collect from medical records the number of procedures that were completed and performed as theoretically intended.

Secondary Outcome Measures

Name	Time	Method
Number of discogel® injections by sclerose of the lesion	Year: 2	Efficacity of the technique
Safety of the technique by number of adverse event	Year: 2	collect in the medical record

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France