CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Sclerotherapy +1 moredrug
Likely dose
Sclerotherapy 3 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01408732
NCT01408732Phase 2Completed

Office-sclerotherapy for Epistaxis Due to Hereditary Hemorrhagic Telangiectasia

University of Minnesota·interventional·Posted Aug 3, 2011·Updated Nov 1, 2019

In Brief

A Phase 2 clinical trial evaluating Sclerotherapy and Standard Treatment for Epistaxis and Hereditary Hemorrhagic Telangiectasia. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2011
Enrollment StartFeb 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.9 years ago

Interventions

Sclerotherapydrug

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.

Standard Treatmentother

Normal standard of care followed by Drug interevention