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Trial record 73 of 591 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids

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ClinicalTrials.gov Identifier: NCT03805087
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Humanitas Clinical and Research Center

Tracking Information
First Submitted Date  ICMJE December 24, 2018
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Estimated Study Start Date  ICMJE January 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
Changes in the severity of symptoms of hemorrhoidal disease [ Time Frame: 1 years ]
A symptom-based severity score (Sordegren scoring system) will be used before and after intervention. It is a questionnaire composed by 4 questions with a final scoring of 0-14 where 14 is the highest possible severity of symptoms. The questionnaire will be administered the day before procedure, one week after procedure and one year after procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Official Title  ICMJE Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Brief Summary This study will evaluate short , mid and long term efficacy of transarterial coil embolization of the superior rectal arteries (Emborrhoid techinque) for treatment the hemorrhoidal disease.
Detailed Description

The 'emborrhoid' technique is the embolization of the hemorrhoidal arteries. The endovascular arterial occlusion is performed using coils placed in the terminal branches of the superior rectal arteries The emborrhoid technique has been modeled after elective transanal Doppler-guided hemorrhoidal artery ligation, which has been shown to be safe and effective for hemorrhoidal disease.

To date, there are few reports regarding emborrhoid, particularly lacking in long-term follow-up. Additionally, all procedures reported so far have used a transfemoral access route, which requires at least one day of hospital stay.

The aims of this study are:

To increase data regarding safety and efficacy of the Emborrhoid technique To report changes in the quality of life of patients at short and long-term To quantify recurrences at one-year follow-up To validate the use of the radial access for the Emborrhoid technique To validate the Emborrhoid technique as a "one-day" hospital procedure

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemorrhoids
  • Embolization, Therapeutic
Intervention  ICMJE Procedure: Transarterial coil embolization
Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
Study Arms  ICMJE Experimental: Coil embolization
Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
Intervention: Procedure: Transarterial coil embolization
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with at least grade II Hemorrhoids (Banov et al. 1985), agreeing to undergo the Embhorroid technique.

Exclusion Criteria:

  • Absolute contraindications to an angiographic procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: EZIO LANZA, MD 0282247383 eziolanza@gmail.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03805087
Other Study ID Numbers  ICMJE ICH-Emborrhoid
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Humanitas Clinical and Research Center
Study Sponsor  ICMJE Humanitas Clinical and Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: EZIO LANZA, MD HUMANITAS RESEARCH HOSPITAL
PRS Account Humanitas Clinical and Research Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP