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Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

NCT01408732 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-11-01

Study results available
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Summary

The purpose of this study is to test a novel and tolerable office-based treatment method, sclerotherapy with sodium tetradecyl sulfate, for recurrent epistaxis (nosebleeds) related to Hereditary Hemorrhagic Telangiectasia (HHT) disease.

Conditions

  • Epistaxis
  • Hereditary Hemorrhagic Telangiectasia

Interventions

DRUG

Sclerotherapy

3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected The amount of foam injected into each lesion varies between 0.1 cc to 0.25 cc. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. During each session, several lesions can be treated, but the total amount of STS used does not exceed 3 cc.

OTHER

Standard Treatment

Normal standard of care followed by Drug interevention

Sponsors & Collaborators

Principal Investigators

  • Holly Boyer, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408732 on ClinicalTrials.gov