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SRAE With Embospheres for Hemorrhoids.

Primary Purpose

Embolization, Hemorrhoids

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Embolization with tri-acryl gelatin (Embosphere) particles

About this trial

This is an interventional treatment trial for Embolization focused on measuring Hemorrhoids, Superior rectal artery, embolization, microspheric particles

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional RadiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Embospheres 500-700 microns

Embospheres 700-900 microns

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of procedure related mortality (safety)

The mortality rate among the patients during 12 months related with interventional procedure.

Incidence of procedure related complications (safety)

The morbidity rate among the patients during 12 months related with interventional procedure.

Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)

The efficacy and clinical success of the procedure will be evaluated

Secondary Outcome Measures

Technical success

The rate of interventions that were performed successfully.

Recurrence

Recanalization or collateralization of the previously embolized rectal arteries.

Full Information

NCT ID

NCT03740321

First Posted

November 8, 2018

Last Updated

November 9, 2018

Sponsor

Eskisehir Osmangazi University

1. Study Identification

Unique Protocol Identification Number

NCT03740321

Brief Title

SRAE With Embospheres for Hemorrhoids.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2018 (Anticipated)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Embolization, Hemorrhoids

Keywords

Hemorrhoids, Superior rectal artery, embolization, microspheric particles

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Blocked randomized, single blind, prospective study

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Embospheres 500-700 microns

Arm Type

Experimental

Arm Description

Arm Title

Embospheres 700-900 microns

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Embolization with tri-acryl gelatin (Embosphere) particles

Other Intervention Name(s)

Embosphere

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of procedure related mortality (safety)

Description

The mortality rate among the patients during 12 months related with interventional procedure.

Time Frame

12 month

Title

Incidence of procedure related complications (safety)

Description

The morbidity rate among the patients during 12 months related with interventional procedure.

Time Frame

12 month

Title

Incidence of the patients' being free of symptoms from hemorrhoidal disease (efficacy)

Description

The efficacy and clinical success of the procedure will be evaluated

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Technical success

Description

The rate of interventions that were performed successfully.

Time Frame

On the day of intervention

Title

Recurrence

Description

Recanalization or collateralization of the previously embolized rectal arteries.

Time Frame

3-6-12. months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fahrettin Kucukay, Prof.

Phone

+905325875318

fkucukay@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fahrettin Kucukay

Organizational Affiliation

Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology

Official's Role

Study Chair

Facility Information:

Facility Name

Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology

City

Eskişehir

ZIP/Postal Code

26450

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fahrettin Kucukay, Prof.

Phone

+905325875318

fkucukay@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27597728

Citation

Zakharchenko A, Kaitoukov Y, Vinnik Y, Tradi F, Sapoval M, Sielezneff I, Galkin E, Vidal V. Safety and efficacy of superior rectal artery embolization with particles and metallic coils for the treatment of hemorrhoids (Emborrhoid technique). Diagn Interv Imaging. 2016 Nov;97(11):1079-1084. doi: 10.1016/j.diii.2016.08.002. Epub 2016 Aug 31.

Results Reference

result

PubMed Identifier

25366092

Citation

Vidal V, Sapoval M, Sielezneff Y, De Parades V, Tradi F, Louis G, Bartoli JM, Pellerin O. Emborrhoid: a new concept for the treatment of hemorrhoids with arterial embolization: the first 14 cases. Cardiovasc Intervent Radiol. 2015 Feb;38(1):72-8. doi: 10.1007/s00270-014-1017-8. Epub 2014 Nov 4.

Results Reference

result

PubMed Identifier

24589187

Citation

Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28.

Results Reference

result

PubMed Identifier

11858033

Citation

Galkin E. [X-ray endovascular embolization of the superior rectal artery: New potentialities in the surgical management of chronic hemorrhoids]. Vestn Rentgenol Radiol. 2001 Nov-Dec;(6):44-9. Russian.

Results Reference

result

PubMed Identifier

29724519

Citation

Tradi F, Louis G, Giorgi R, Mege D, Bartoli JM, Sielezneff I, Vidal V. Embolization of the Superior Rectal Arteries for Hemorrhoidal Disease: Prospective Results in 25 Patients. J Vasc Interv Radiol. 2018 Jun;29(6):884-892.e1. doi: 10.1016/j.jvir.2018.01.778. Epub 2018 Apr 30.

Results Reference

result

PubMed Identifier

29797246

Citation

Venturini M, De Nardi P, Marra P, Panzeri M, Brembilla G, Morelli F, Melchiorre F, De Cobelli F, Del Maschio A. Embolization of superior rectal arteries for transfusion dependent haemorrhoidal bleeding in severely cardiopathic patients: a new field of application of the "emborrhoid" technique. Tech Coloproctol. 2018 Jun;22(6):453-455. doi: 10.1007/s10151-018-1802-5. Epub 2018 May 24. No abstract available.

Results Reference

result

PubMed Identifier

29042023

Citation

Primo Romaguera V, Gregorio Hernandez A, Andreo Hernandez L, de la Morena Valenzuela E. Selective embolization of the superior rectal artery: An alternative to hemorrhoid surgery? Cir Esp (Engl Ed). 2018 Apr;96(4):239-241. doi: 10.1016/j.ciresp.2017.08.005. Epub 2017 Oct 14. No abstract available. English, Spanish.

Results Reference

result

Links:

URL

https://www.merit.com/interventional-oncology-spine/embolotherapy/microspheres/embosphere-microspheres/

Description

Device descriptions, Instructions for use

Learn more about this trial

SRAE With Embospheres for Hemorrhoids.

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