Fistulas ArteriovenousNCT06480331

Radiation Free Fistuloplasty is the Way Forward

A study testing Ultrasound-guided fistuloplasty and Fluoroscopy-guided fistuloplasty in people with Fistulas Arteriovenous, run by University of Malaya at 2 sites in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Fistulas Arteriovenous
What is being tested?: Ultrasound-guided fistuloplasty and Fluoroscopy-guided fistuloplasty
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesMalaysia
Study dates: 1 Jul 2023to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient able to comprehend English or Malay language.
Patient aged ⩾18 years and ⩽80 years.
Patient is willing to comply with protocol.
Native AVF that is able to provide prescribed dialysis consistently with 2 needles for >2/3 of dialysis sessions within 4 consecutive weeks.
Patient has a reasonable expectation of remaining on haemodialysis for 6 months.
Dampened thrill or pulsatile flow.
Volume flow (VF) <500 ml/min.
Severe stenosis (>50%) of arteriovenous (AV) access measured on color image and confirmed by peak systolic velocity (PSV) ratio of ≥3 in the inflow artery, anastomosis, or in the outflow vein.

Who cannot join

Prior history of fistuloplasty.
Thrombosed or completely occluded fistula or outflow vein.
Non-mature AVF.
Arteriovenous grafts.
Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.
Non consenting patient.

Show all 15Show fewer

Metastatic cancer or terminal medical condition.
Limited life expectancy (<6 months).
Blood coagulation disorders (haemophilia/ Von Willebrand disease/ clotting factor deficiencies/ liver disease).
Connective tissue disease (rheumatoid arthritis/ lupus).
Sepsis or active infection.
Planned access abandonment within 6 months (eg, peritoneal dialysis or transplant).
Pregnant women or women of childbearing potential who are not following an effective method of contraception.
Allergy or other known contraindication to iodinated media contrast.
Patient enrolled in another access maintenance trial.

Trial locations and contacts

2 sites in 1 country.

Ehab Bin Said contact

0196343874

ehab.said.talib@gmail.com

Malaysia2 sites, 2 recruiting

Kuala Lumpur Hospital, Jalan Pahang,
Kuala Lumpur, Kuala Lumpur, 50586
Ehab Bin Said, 0196343874, ehab.said.talib@gmail.com
Recruiting
University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13,
Petaling Jaya, Kuala Lumpur, 50603
Ehab Bin Said, 0196343874, ehab.said.talib@gmail.com
Recruiting

Other trials in Malaysia

About this study

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

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.

Read the 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 1:1 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 500ml/min 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.

Conditions: Fistulas Arteriovenous
Being tested: Ultrasound-guided fistuloplasty, Fluoroscopy-guided fistuloplasty
Keywords: Endovascular treatments, Percutaneous, Ultrasound
Medical subject headings: Arteriovenous Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound-guided fistuloplastyProcedure or surgery
Radiation free fistuloplasty
Fluoroscopy-guided fistuloplastyProcedure or surgery
Conventional fistuloplasty

Study groups in NCT06480331
Study group	Role	What they receive
Ultrasound-guided fistuloplasty	Experimental	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 500ml/min signifies the end points of the procedure. 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. Receives: Procedure: Ultrasound-guided fistuloplasty
Fluoroscopy-guided fistuloplasty	Active comparator	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 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. Receives: Procedure: Fluoroscopy-guided fistuloplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months
The duration of time from intervention to thrombosis or any re-intervention to facilitate, maintain, or re-establish patency
Measured: 6 months

Secondary outcomes (3)

To capture data regarding variables that may affect patency of arteriovenous access flow dysfunction post ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
These includes demographic data (comorbidities, smoking history, gender, patient's age, age of fistula) and anatomic location of lesion and number of lesion.
Measured: Over the course of six months follow-up
To compare technical success in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
Technical success is defined as clinical palpable thrill, radiographic finding of less than 30% recoil and ultrasonographic finding of continuous segment of dilated vein to 5-6mm and continuous flow rate of more than 500ml/min
Measured: Immediately post operation
To compare complication rates in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
This includes thrombosis, pseudoaneurysm and bleeding
Measured: Immediately post operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202331 Dec 2024

First posted28 Jun 2024
Study start1 Jul 2023
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Fistulas ArteriovenousStudies of the same condition, open and under way.
More trials run by University of MalayaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06480331
Sponsor's protocol ID: NMRR ID-23-01273-4HI
Status last verified: May 2024
First submitted: 24 Jun 2024
Last updated: 28 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in ultrasound guided fistuloplasty.

Publications

Pisoni RL, Arrington CJ, Albert JM, Ethier J, Kimata N, Krishnan M, Rayner HC, Saito A, Sands JJ, Saran R, Gillespie B, Wolfe RA, Port FK. Facility hemodialysis vascular access use and mortality in countries participating in DOPPS: an instrumental variable analysis. Am J Kidney Dis. 2009 Mar;53(3):475-91. doi: 10.1053/j.ajkd.2008.10.043. Epub 2009 Jan 15.
PubMed 19150158
Tordoir JH, de Bruin HG, Hoeneveld H, Eikelboom BC, Kitslaar PJ. Duplex ultrasound scanning in the assessment of arteriovenous fistulas created for hemodialysis access: comparison with digital subtraction angiography. J Vasc Surg. 1989 Aug;10(2):122-8. doi: 10.1067/mva.1989.0100122.
PubMed 2668564
Leskovar B, Furlan T, Poznic S, Potisek M, Adamlje A, Kljucevsek T. Ultrasound-guided percutaneous endovascular treatment of arteriovenous fistula/graft. Clin Nephrol. 2017 Supplement 1;88(13):61-64. doi: 10.5414/CNP88FX15.
PubMed 28655388
Cho S, Lee YJ, Kim SR. Clinical experience with ultrasound guided angioplasty for vascular access. Kidney Res Clin Pract. 2017 Mar;36(1):79-85. doi: 10.23876/j.krcp.2017.36.1.79. Epub 2017 Mar 31.
PubMed 28393000
Wakabayashi M, Hanada S, Nakano H, Wakabayashi T. Ultrasound-guided endovascular treatment for vascular access malfunction: results in 4896 cases. J Vasc Access. 2013 Jul-Sep;14(3):225-30. doi: 10.5301/jva.5000126. Epub 2013 Jan 8.
PubMed 23334852
Gorin DR, Perrino L, Potter DM, Ali TZ. Ultrasound-guided angioplasty of autogenous arteriovenous fistulas in the office setting. J Vasc Surg. 2012 Jun;55(6):1701-5. doi: 10.1016/j.jvs.2011.12.016. Epub 2012 Jan 23.
PubMed 22265799
Ascher E, Hingorani A, Marks N. Duplex-guided balloon angioplasty of failing or nonmaturing arterio-venous fistulae for hemodialysis: a new office-based procedure. J Vasc Surg. 2009 Sep;50(3):594-9. doi: 10.1016/j.jvs.2009.03.061.
PubMed 19595550
Marks N, Hingorani A, Ascher E. New office-based vascular interventions. Perspect Vasc Surg Endovasc Ther. 2008 Dec;20(4):340-5. doi: 10.1177/1531003508327921. Epub 2008 Nov 19.
PubMed 19022786
Marks N, Ascher E, Hingorani AP. Duplex-guided repair of failing or nonmaturing arterio-venous access for hemodialysis. Perspect Vasc Surg Endovasc Ther. 2007 Mar;19(1):50-5. doi: 10.1177/1531003506298144.
PubMed 17437980
Bacchini G, Cappello A, La Milia V, Andrulli S, Locatelli F. Color doppler ultrasonography imaging to guide transluminal angioplasty of venous stenosis. Kidney Int. 2000 Oct;58(4):1810-3. doi: 10.1046/j.1523-1755.2000.00344.x.
PubMed 11012917
Karmota AG. Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access. Ann R Coll Surg Engl. 2020 Oct;102(8):601-605. doi: 10.1308/rcsann.2020.0121. Epub 2020 Jun 15.
PubMed 32538115
Fox D, Amador F, Clarke D, Velez M, Cruz J, Labropoulos N, Ryan M, Gelman L. Duplex guided dialysis access interventions can be performed safely in the office setting: techniques and early results. Eur J Vasc Endovasc Surg. 2011 Dec;42(6):833-41. doi: 10.1016/j.ejvs.2011.04.020. Epub 2011 May 4.
PubMed 21531585
Wittenberg G, Kellner M, Kenn W, Obert A, Schultz G, Trusen A, Tschammler A, Gotz R, Hahn D. [Initial experiences with dilatation of dialysis shunts with color-coded duplex ultrasonography monitoring]. Rofo. 1996 Jan;164(1):38-41. doi: 10.1055/s-2007-1015605. German.
PubMed 8630358

Want to know more?

Ehab Bin Said

0196343874

ehab.said.talib@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Fistulas Arteriovenous trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06480331
Acronym / sponsor ID: NMRR ID-23-01273-4HI
Conditions: Fistulas Arteriovenous
Keywords: Endovascular treatments, Percutaneous, Ultrasound
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 54 participants (estimated)
Lead sponsor: University of MalayaUniversity, hospital or other
Study start: 1 Jul 2023 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 28 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

After assessing for eligibility, patients will be randomized equally with a ratio 1:1 to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ultrasound-guided fistuloplasty	Experimental	Procedure: Ultrasound-guided fistuloplastyAfter 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 500ml/min signifies the end points of the procedure. 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.
Fluoroscopy-guided fistuloplasty	Active comparator	Procedure: Fluoroscopy-guided fistuloplastyAfter 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 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient able to comprehend English or Malay language.
Patient aged ⩾18 years and ⩽80 years.
Patient is willing to comply with protocol.
Native AVF that is able to provide prescribed dialysis consistently with 2 needles for >2/3 of dialysis sessions within 4 consecutive weeks.
Patient has a reasonable expectation of remaining on haemodialysis for 6 months.

Key exclusion criteria (15 listed)

Prior history of fistuloplasty.
Thrombosed or completely occluded fistula or outflow vein.
Non-mature AVF.
Arteriovenous grafts.
Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ultrasound-guided fistuloplastyRadiation free fistuloplasty	Procedure or surgery	Ultrasound-guided fistuloplasty
Fluoroscopy-guided fistuloplastyConventional fistuloplasty	Procedure or surgery	Fluoroscopy-guided fistuloplasty

Primary outcome

To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months
Time frame: 6 months
The duration of time from intervention to thrombosis or any re-intervention to facilitate, maintain, or re-establish patency

3 secondary outcomes

To capture data regarding variables that may affect patency of arteriovenous access flow dysfunction post ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
Time frame: Over the course of six months follow-up
To compare technical success in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
Time frame: Immediately post operation
To compare complication rates in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty
Time frame: Immediately post operation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
Background: PubMed 19150158Pisoni RL, Arrington CJ, Albert JM, Ethier J, Kimata N, Krishnan M, Rayner HC, Saito A, Sands JJ, Saran R, Gillespie B, Wolfe RA, Port FK. Facility hemodialysis vascular access use and mortality in countries participating in DOPPS: an instrumental variable analysis. Am J Kidney Dis. 2009 Mar;53(3):475-91. doi: 10.1053/j.ajkd.2008.10.043. Epub 2009 Jan 15.
Background: PubMed 2668564Tordoir JH, de Bruin HG, Hoeneveld H, Eikelboom BC, Kitslaar PJ. Duplex ultrasound scanning in the assessment of arteriovenous fistulas created for hemodialysis access: comparison with digital subtraction angiography. J Vasc Surg. 1989 Aug;10(2):122-8. doi: 10.1067/mva.1989.0100122.
Background: PubMed 28655388Leskovar B, Furlan T, Poznic S, Potisek M, Adamlje A, Kljucevsek T. Ultrasound-guided percutaneous endovascular treatment of arteriovenous fistula/graft. Clin Nephrol. 2017 Supplement 1;88(13):61-64. doi: 10.5414/CNP88FX15.
Background: PubMed 28393000Cho S, Lee YJ, Kim SR. Clinical experience with ultrasound guided angioplasty for vascular access. Kidney Res Clin Pract. 2017 Mar;36(1):79-85. doi: 10.23876/j.krcp.2017.36.1.79. Epub 2017 Mar 31.
Background: PubMed 23334852Wakabayashi M, Hanada S, Nakano H, Wakabayashi T. Ultrasound-guided endovascular treatment for vascular access malfunction: results in 4896 cases. J Vasc Access. 2013 Jul-Sep;14(3):225-30. doi: 10.5301/jva.5000126. Epub 2013 Jan 8.
Background: PubMed 22265799Gorin DR, Perrino L, Potter DM, Ali TZ. Ultrasound-guided angioplasty of autogenous arteriovenous fistulas in the office setting. J Vasc Surg. 2012 Jun;55(6):1701-5. doi: 10.1016/j.jvs.2011.12.016. Epub 2012 Jan 23.
Background: PubMed 19595550Ascher E, Hingorani A, Marks N. Duplex-guided balloon angioplasty of failing or nonmaturing arterio-venous fistulae for hemodialysis: a new office-based procedure. J Vasc Surg. 2009 Sep;50(3):594-9. doi: 10.1016/j.jvs.2009.03.061.
Background: PubMed 19022786Marks N, Hingorani A, Ascher E. New office-based vascular interventions. Perspect Vasc Surg Endovasc Ther. 2008 Dec;20(4):340-5. doi: 10.1177/1531003508327921. Epub 2008 Nov 19.
Background: PubMed 17437980Marks N, Ascher E, Hingorani AP. Duplex-guided repair of failing or nonmaturing arterio-venous access for hemodialysis. Perspect Vasc Surg Endovasc Ther. 2007 Mar;19(1):50-5. doi: 10.1177/1531003506298144.
Background: PubMed 11012917Bacchini G, Cappello A, La Milia V, Andrulli S, Locatelli F. Color doppler ultrasonography imaging to guide transluminal angioplasty of venous stenosis. Kidney Int. 2000 Oct;58(4):1810-3. doi: 10.1046/j.1523-1755.2000.00344.x.
Background: PubMed 32538115Karmota AG. Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access. Ann R Coll Surg Engl. 2020 Oct;102(8):601-605. doi: 10.1308/rcsann.2020.0121. Epub 2020 Jun 15.
Background: PubMed 21531585Fox D, Amador F, Clarke D, Velez M, Cruz J, Labropoulos N, Ryan M, Gelman L. Duplex guided dialysis access interventions can be performed safely in the office setting: techniques and early results. Eur J Vasc Endovasc Surg. 2011 Dec;42(6):833-41. doi: 10.1016/j.ejvs.2011.04.020. Epub 2011 May 4.
Ghanwat SP, Yeramsetti S, Sahu T, Sheorain V, Grover T, Parakh R et al.Link provided by the sponsor.
Banerjee S, Patel HM, Sahu T, Sheorain VK, Grover T, Parakh R et al.Link provided by the sponsor.
Kim JC, Cho JS et al.Link provided by the sponsor.
Individual participant dataSharing planned: No. No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in ultrasound guided fistuloplasty.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ehab Bin Said contact

0196343874

ehab.said.talib@gmail.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided fistuloplasty and Fluoroscopy-guided fistuloplasty in people with Fistulas Arteriovenous, run by University of Malaya at 2 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ehab Bin Said (0196343874, ehab.said.talib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06480331, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.