NCT03740321

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 8, 2018

Last Update Submit

November 9, 2018

Conditions

EmbolizationHemorrhoids

Keywords

HemorrhoidsSuperior rectal arteryembolizationmicrospheric particles

Outcome Measures

Primary Outcomes (3)

  • Incidence of procedure related mortality (safety)

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

    12 month

  • Incidence of procedure related complications (safety)

    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)

    The efficacy and clinical success of the procedure will be evaluated

    12 month

Secondary Outcomes (2)

  • Technical success

    On the day of intervention

  • Recurrence

    3-6-12. months

Study Arms (2)

Embospheres 500-700 microns

EXPERIMENTAL

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

Embospheres 700-900 microns

EXPERIMENTAL

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

Interventions

Embolization with tri-acryl gelatin (Embosphere) particlesDEVICE

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.

Also known as: Embosphere
Embospheres 500-700 micronsEmbospheres 700-900 microns

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Eskişehir, 26450, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

    PMID: 27597728RESULT

  • 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.

    PMID: 25366092RESULT

  • 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.

    PMID: 24589187RESULT

  • 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.

    PMID: 11858033RESULT

  • 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.

    PMID: 29724519RESULT

  • 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.

    PMID: 29797246RESULT

  • 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.

    PMID: 29042023RESULT

Related Links

MeSH Terms

Conditions

Hemorrhoids

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Fahrettin Kucukay

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

    STUDY CHAIR

Central Study Contacts

Fahrettin Kucukay, Prof.

CONTACT

+905325875318fkucukay@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Blocked randomized, single blind, prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 14, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)