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

March 8, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint-Etienne
        • Principal Investigator:
          • Sylvain Grange, MD
        • Sub-Investigator:
          • Valentin Gineys, resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel will be included.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel®

Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® will be included.

Analysis datas of medical record.
Other: datas of medical record.

Analysis datas of medical record:

  • Feasibility of the technique
  • Safety of the technique
  • Efficacity (sclerose of the lesion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the technique
Time Frame: Year: 2
Collect from medical records the number of procedures that were completed and performed as theoretically intended.
Year: 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the technique by number of adverse event
Time Frame: Year: 2
collect in the medical record
Year: 2
Number of discogel® injections by sclerose of the lesion
Time Frame: Year: 2
Efficacity of the technique
Year: 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Sylvain GRANGE, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN552022/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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