Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03805087
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2018-12-24
Brief Title:
Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Sponsor:
Humanitas Clinical and Research Center
Organization:
Humanitas Clinical and Research Center
Study Overview
Official Title:
Transarterial Coil Embolization of the Superior Rectal Arteries for Treatment of Stage II Hemorrhoids
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None