NCT03257930

Brief Summary

Use of ethanol injection in treatment of cystic thyroid nodule

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

August 17, 2017

Last Update Submit

May 13, 2020

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • Reduction of volume of the cyst about 96.9%

    Reduction of volume of the cyst about 96.9%

    Reduction of volume of the cyst about 96.9% within 6 month

Secondary Outcomes (1)

  • symptomatic improvement

    3 month

Study Arms (1)

injection of ethanol

EXPERIMENTAL

use of ethanol injection in the treatment of cystic thyroid nodule

Drug: ethanol injection

Interventions

ethanol injectionDRUG

inject ethanol in cystic thyroid nodule and follow up until complete recovery

injection of ethanol

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult male or female patient with cystic thyroid nodule
  • Presence of pressure symptoms or cosmetic problems
  • Benign lesions confirmed by histopathological examination by FNAC.
  • Serum levels of thyroid hormone thyrotropin, within normal limits.

You may not qualify if:

  • Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US
  • solid thyroid nodule
  • mixed thyroid nodule(cystic with solid component)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (2)

  • Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available.

    PMID: 21087BACKGROUND

  • Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. doi: 10.1210/jcem.78.3.8126160.

    PMID: 8126160BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
general surgery

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 22, 2017

Study Start

August 11, 2017

Primary Completion

July 11, 2018

Study Completion

January 1, 2019

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

EG(1)