Percutaneous Gelled Alcohol Sclerotherapy for Aggressive Angiomas: Evaluation of Feasibility, Safety, and Efficacy

October 7, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
The investigators aimed to evaluate efficacy and safety of a non-surgical protocol treatment combining transarterial embolization and percutaneous radiopaque gelled ethanol (RGE) sclerotherapy in a first procedure, then followed by vertebroplasty in a second procedure, to treat aggressive vertebral hemangioma patients in tertiary hospital. Exclusion criteria were age <18-years old and any association with neurological deficit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

11

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 Locations

  • France
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • CHU de Saint-Etienne
        • Principal Investigator:
          • Sylvain GRANGE, MD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Étienne University Hospital will be included.

Description

Inclusion Criteria:

  • Every patients treated by gelled alcohol sclerotherapy for aggressive angiomas, in the University Hospital of Saint-Etienne.

Exclusion Criteria:

  • Patients no treated by gelled alcohol sclerotherapy.

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
Study population
Patients who have undergone percutaneous gel ethanol sclerosis for aggressive bone angioma at Saint-Etienne University Hospital.
Other: Collecting data from medical records
Data collected: clinical data (particularly pain), biological data, imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of complications identified in data collection
Time Frame: Day 1
Number of complications identified in data collection
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lesion identified in data collection
Time Frame: Day 1
Number of lesion identified in data collection
Day 1

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)

June 25, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN312024/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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