Varicose VeinsNCT05508581
Microwaves Ablation of Varicose Veins
A study testing microwaves ablation of varicose veins in people with Varicose Veins, run by Assiut University at 1 site in Egypt.
Trial summary
Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- microwaves ablation of varicose veins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 15 Dec 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years, either sex, elective admission
- primary symptomatic VVS (CEAP,C3-C6)
- Recurrent Varicose Veins after surgery
- Greater saphenous vein diameter up to 3 cm
- Greater saphenous vein with variable depth even with depth less than 6mm
- Greater saphenous vein with tortuosity
Show all 9Show fewer
- Diabetic patient with risk of wound infection after surgery
- Patient with hostile groin
- Availability of patients for all follow-up visits
Who cannot join
- secondary Varicose Veins
- Acute thrombosis near the Saphenous-femoral junction
- Recanalized Greater saphenous vein
- pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years
Asyut
About this study
Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives.
Read the detailed description
Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives. Endo venous thermal ablation, such as radiofrequency ablation and endo venous laser ablation (EVLA), has become the recommended first-line treatment for VVs worldwide. These endo venous procedures provide a quicker recovery time and improved QoL and produce fewer complications than traditional surgery .Endo venous microwaves ablation is a minimally invasive procedure in treatment of V.V, investigators confirmed that endo venous microwave ablation (EMA) was an effective new technique for the treatment of VVs. On previous trials confirmed that the endo venous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endo venous laser ablation procedure. The aim of the study was to determine whether endo venous microwave ablation of varicose vein was associated with better effectiveness and less complications and evaluate the outcome of patients who underwent endo venous microwave ablation (EMA).
- Conditions
- Varicose Veins
- Being tested
- microwaves ablation of varicose veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwaves ablation of varicose veinsProcedure or surgery
Microwave ablation is an endovenous treatment. This is a similar treatment approach as laser ablation and radiofrequency ablation. "Endovenous" means that the treatment device is inside the vein during treatment.
| Study group | Role | What they receive |
|---|---|---|
| Varicose veins | Other | Ablation of varicose veins by microwaves Receives: Procedure: microwaves ablation of varicose veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Number of Participants with Lack of flow or closed great saphenous vein
Complete ablation of varicose veins done or if any residual remind
Measured: 6 months
2.Operation time
The time of the whole procedure
Measured: Intraoperative
Secondary outcomes (2)
1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation
Reopening of the Varicose veins
Measured: 12 month
2. Number of Participants with adverse effect of the procedure
Thrombophlebitis,Infection or blood loss
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Nov 2022
- Primary completion31 Oct 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, joseph samy youssef saleeb, Assiut University
- Investigators
- Mohamed Gamal glal, Lecturer, Study chair, Lecturer at Vascular and endovascular surgery department Assuit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508581
- Sponsor's protocol ID
- Microwaves ablation
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwaves Ablation of Varicose Veins
- ClinicalTrials.gov ID
- NCT05508581
- Acronym / sponsor ID
- Microwaves ablation
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 19 Aug 2022 (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.
Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives.
Detailed description
Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives. Endo venous thermal ablation, such as radiofrequency ablation and endo venous laser ablation (EVLA), has become the recommended first-line treatment for VVs worldwide. These endo venous procedures provide a quicker recovery time and improved QoL and produce fewer complications than traditional surgery .Endo venous microwaves ablation is a minimally invasive procedure in treatment of V.V, investigators confirmed that endo venous microwave ablation (EMA) was an effective new technique for the treatment of VVs. On previous trials confirmed that the endo venous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endo venous laser ablation procedure. The aim of the study was to determine whether endo venous microwave ablation of varicose vein was associated with better effectiveness and less complications and evaluate the outcome of patients who underwent endo venous microwave ablation (EMA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varicose veins | Other | Procedure: microwaves ablation of varicose veinsAblation of varicose veins by microwaves |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 18 and 60 years, either sex, elective admission
- primary symptomatic VVS (CEAP,C3-C6)
- Recurrent Varicose Veins after surgery
- Greater saphenous vein diameter up to 3 cm
- Greater saphenous vein with variable depth even with depth less than 6mm
Key exclusion criteria (4 listed)
- secondary Varicose Veins
- Acute thrombosis near the Saphenous-femoral junction
- Recanalized Greater saphenous vein
- pregnancy
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 |
|---|---|---|
| microwaves ablation of varicose veinsMicrowave ablation is an endovenous treatment. This is a similar treatment approach as laser ablation and radiofrequency ablation. "Endovenous" means that the treatment device is inside the vein during treatment. | Procedure or surgery | Varicose veins |
Primary outcome
1.Number of Participants with Lack of flow or closed great saphenous vein
Time frame: 6 months
Complete ablation of varicose veins done or if any residual remind
2.Operation time
Time frame: Intraoperative
The time of the whole procedure
2 secondary outcomes
1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation
Time frame: 12 month
2. Number of Participants with adverse effect of the procedure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Mohamed Gamal glal, Lecturer study chair
Lecturer at Vascular and endovascular surgery department Assuit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microwaves ablation of varicose veins in people with Varicose Veins, run by Assiut University at 1 site in Egypt.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Number of Participants with Lack of flow or closed great saphenous vein (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.