Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480331
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Radiation Free Fistuloplasty is the Way Forward
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
The goal of this clinical trial is to study effectiveness of ultrasound-guided fistuloplasty in comparison to conventional fistuloplasty in patients with arteriovenous access flow dysfunction The main question it aims to answer is
To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months
Participants will
be randomized equally to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group
visit clinic at one month three month six months for checkups and tests
To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months
Participants will
be randomized equally to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group
visit clinic at one month three month six months for checkups and tests
Detailed Description:
This is an experimental study employing a prospective randomized controlled trial to determine the efficacy of ultrasound-guided fistuloplasty compared to fluoroscopy-guided fistuloplasty in patients with arteriovenous access flow dysfunction
After assessing for eligibility patients will be randomized equally with a ratio 11 to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group
Both interventions will be done in operation theatre to maintain sterility After cleaning and draping the area of interest local anaesthesia is given to the puncture site A puncture needle is used to gain access to the arteriovenous fistula followed by a guide wire Then a sheath with an appropriate size is placed and a balloon catheter of adequate size is inserted over the guide wire and inflated for 2 minutes Ultrasound is used in the subject group to monitor technical success On table visualization of continuous segment of dilated vein to 5-6mm and continuous flow rate of more than 500mlmin signifies the end points of the procedure Fluoroscopy is used in the control group to assess for technical success On table fistulogram visualization of less than 30 recoil of the target lesion signifies technical success After a satisfactory result a figure of 8 suture is placed with manual inflow occlusion Post procedure patients will be observed for any signs of haematoma or bleeding If there are no immediate complications patients will be discharged on the same day
After assessing for eligibility patients will be randomized equally with a ratio 11 to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group
Both interventions will be done in operation theatre to maintain sterility After cleaning and draping the area of interest local anaesthesia is given to the puncture site A puncture needle is used to gain access to the arteriovenous fistula followed by a guide wire Then a sheath with an appropriate size is placed and a balloon catheter of adequate size is inserted over the guide wire and inflated for 2 minutes Ultrasound is used in the subject group to monitor technical success On table visualization of continuous segment of dilated vein to 5-6mm and continuous flow rate of more than 500mlmin signifies the end points of the procedure Fluoroscopy is used in the control group to assess for technical success On table fistulogram visualization of less than 30 recoil of the target lesion signifies technical success After a satisfactory result a figure of 8 suture is placed with manual inflow occlusion Post procedure patients will be observed for any signs of haematoma or bleeding If there are no immediate complications patients will be discharged on the same day
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