SRAE With Embospheres for Hemorrhoids.

November 9, 2018 updated by: Fahrettin Kucukay,MD, Eskisehir Osmangazi University

Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy

In this study , safety and efficacy of superior rectal artery embolization with embospheres will be researched prospectively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Symptomatic hemorrhoidal disease is a still important public health problem although there are many surgical and nonsurgical minimal invasive treatment methods. Treatment methods are not satisfactory or invasive in some percent of the patients. Superior rectal artery embolization(SRAE) for hemorrhoids is an adapted technique derived from Doppler-guided hemorrhoidal artery ligation (DGHAL). In this technique, the distal branches of the superior rectal artery arising from the inferior mesenteric artery is occluded endovascularly with coils. Its feasibility and safety were supported by articles. Collateralization and recurrence was seen following coil embolization. To prevent this , tri-acryl gelatin microspheres in 500-700 and 700-900 micrometers in size will be used. Safety and efficacy of embolization and using different sized particles will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Eskişehir, Turkey, 26450
        • Recruiting
        • Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symptoms of hemorrhoidal disease
  • Patients with written informed consent
  • Patients refusing surgery or other interventional methods
  • Patients with high risk for surgery
  • Patients accepting follow ups

Exclusion Criteria:

  • Previous intervention
  • Colorectal diseases other than hemorrhoids
  • Patients with anal stenosis
  • Patients with rectal prolapsus
  • pregnant patients
  • Patients with contraindications for technical steps or contrast usage.
  • Patients do nor or could not give written informed consent

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Embospheres 500-700 microns
Intervention.Embolization with 500-700 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time.
Device: Embolization with tri-acryl gelatin (Embosphere) particles
Left, right and posterior branches of superior rectal artery will be embolized with tri-acryl gelatin particles in 500-700 and 700-900 micrometers in size until homeostasis will be achieved.
Other Names:
  • Embosphere
Experimental: Embospheres 700-900 microns
Intervention.Embolization with 700-900 micron particles will be performed with 1 ml vials. Embolization procedure will be continued with vials until the stasis in SRAE will be achieved. Procedure will be performed only one time.
Device: Embolization with tri-acryl gelatin (Embosphere) particles
Left, right and posterior branches of superior rectal artery will be embolized with tri-acryl gelatin particles in 500-700 and 700-900 micrometers in size until homeostasis will be achieved.
Other Names:
  • Embosphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of procedure related mortality (safety)
Time Frame: 12 month
The mortality rate among the patients during 12 months related with interventional procedure.
12 month
Incidence of procedure related complications (safety)
Time Frame: 12 month
The morbidity rate among the patients during 12 months related with interventional procedure.
12 month
Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)
Time Frame: 12 month
The efficacy and clinical success of the procedure will be evaluated
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: On the day of intervention
The rate of interventions that were performed successfully.
On the day of intervention
Recurrence
Time Frame: 3-6-12. months
Recanalization or collateralization of the previously embolized rectal arteries.
3-6-12. months

Collaborators and Investigators

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

Sponsor

Eskisehir Osmangazi University

Investigators

  • Study Chair: Fahrettin Kucukay, Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80558721/237

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

product manufactured in and exported from the U.S.

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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