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SRAE With Embospheres for Hemorrhoids.

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ClinicalTrials.gov Identifier: NCT03740321
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fahrettin Kucukay,MD, Eskisehir Osmangazi University

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

Condition or disease Intervention/treatment Phase
Embolization Hemorrhoids Device: Embolization with tri-acryl gelatin (Embosphere) particles Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blocked randomized, single blind, prospective study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Superior Rectal Artery Embolization With Tri-acryl Gelatin Particles for Treatment of Symptomatic Hemorrhoids: Safety and Efficacy
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
Drug Information available for: Gelatin

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 Name: 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 Name: Embosphere




Primary Outcome Measures :
  1. Incidence of procedure related mortality (safety) [ Time Frame: 12 month ]
    The mortality rate among the patients during 12 months related with interventional procedure.

  2. Incidence of procedure related complications (safety) [ Time Frame: 12 month ]
    The morbidity rate among the patients during 12 months related with interventional procedure.

  3. 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


Secondary Outcome Measures :
  1. Technical success [ Time Frame: On the day of intervention ]
    The rate of interventions that were performed successfully.

  2. Recurrence [ Time Frame: 3-6-12. months ]
    Recanalization or collateralization of the previously embolized rectal arteries.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740321


Contacts
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Contact: Fahrettin Kucukay, Prof. +905325875318 fkucukay@hotmail.com

Locations
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Turkey
Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology Recruiting
Eskişehir, Turkey, 26450
Contact: Fahrettin Kucukay, Prof.    +905325875318    fkucukay@hotmail.com   
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
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Study Chair: Fahrettin Kucukay Eskisehir Osmangazi University, Faculty of Medicine, Department of Interventional Radiology
  Study Documents (Full-Text)

Documents provided by Fahrettin Kucukay,MD, Eskisehir Osmangazi University:
Study Protocol  [PDF] July 15, 2017


Additional Information:
Publications of Results:

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Responsible Party: Fahrettin Kucukay,MD, Prof.Dr., Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT03740321     History of Changes
Other Study ID Numbers: 80558721/237
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Fahrettin Kucukay,MD, Eskisehir Osmangazi University:
Hemorrhoids
Superior rectal artery
embolization
microspheric particles

Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases