Venous InsufficiencyPhase 1/2NCT01972633
Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
A Phase 1/2 study testing Laser and Radiofrequency in people with Venous Insufficiency, run by Ludwig Boltzmann Institute for Operative Laparoscopy at 1 site in Austria.
Trial summary
There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Laser and Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Apr 2014
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
- maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm
Who cannot join
- surgical treatment of the saphenous vein in the past
- sclerotherapy of the saphenous vein in the past
- phlebitis or thrombosis of the saphenous vein
- surgical treatment of an venous ulcer in the past
- postthrombotic syndrome
- erysipelas of the leg in the past
Show all 16Show fewer
- chronic treatment with pain-killers or chronic alcoholism
- pregnancy
- drug allergy against painkillers that are used in this study
- spinal anesthesia not possible
- compression bandage not possible
- patients with polyneuropathy
- patients with chronic pain
- persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
- participation on an other clinical trial that can interfere with this clinical trial
- missing written informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
2.Chirurgische Abteilung AKh Linz GesmbH
Linz, Upper Austria, 4020
Katharina Bröderbauer, 0043 732 7806 2133, chirurgie2@akh.linz.at
Markus MS Schreiner
About this study
Official title: Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .
Read the detailed description
The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.
In this study there are no additional risk factors for the included study patients except the risk of surgery.
- Conditions
- Venous Insufficiency
- Being tested
- Laser, Radiofrequency
- Keywords
- endovenous treatment, Laser, Vnus Closure Fast, Varicosis, great saphenous vein, small saphenous vein, Venous Insufficiency
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
Endovenous Laser (1470nm) ablation of great or small saphenous vein
RadiofrequencyProcedure or surgery
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
| Study group | Role | What they receive |
|---|---|---|
| 1470nm Laser | Active comparator | Patient with varicose vein treated with 1470nm Laser (Biolitec) Receives: Procedure: Laser; Procedure: Radiofrequency |
| VNUS Closure Fast | Active comparator | Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System) Receives: Procedure: Laser; Procedure: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain (visual analogue scale) on the day of treatment
Measured: day 0
Secondary outcomes (2)
Obliteration of the treated vein (GSV or SSV)
An ultrasound investigation of he treated vein is done to find out if the treated vein is fully obliterated or not. If it is not fully obliterated we want to find out if there is any pathological reflux in the vein.
Measured: day 10, month 3, month 12
Patient´s satisfaction after the intervention
The patient is asked about his/her satisfaction after intervention. This is measured on a numeric scale from 1 to 5 (like schoolmarks in austria or germany). 1=very good, 2=good, 3=average, 4=not so good, 5=bad)
Measured: day 10, month 3, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startJun 2010
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Operative Laparoscopy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Markus Schreiner, Ludwig Boltzmann Institute for Operative Laparoscopy
- Investigators
- Markus Schreiner, Principal investigator, 2.Chirurgische Abteilung AKh Linz GesmbHAndreas Shamiyeh, Study chair, 2. Chirurgische Abteilung AKh Linz GesmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972633
- Sponsor's protocol ID
- Boltzmann-001
- Status last verified
- Oct 2013
- First submitted
- 4 Dec 2012
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
- ClinicalTrials.gov ID
- NCT01972633
- Acronym / sponsor ID
- Boltzmann-001
- Conditions
- Venous Insufficiency
- Keywords
- endovenous treatment, Laser, Vnus Closure Fast, Varicosis, great saphenous vein, small saphenous vein, Venous Insufficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute for Operative LaparoscopyUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 30 Oct 2013 (estimated)
- 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.
There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .
Detailed description
The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.
In this study there are no additional risk factors for the included study patients except the risk of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1470nm Laser | Active comparator | Procedure: Laser, Procedure: RadiofrequencyPatient with varicose vein treated with 1470nm Laser (Biolitec) |
| VNUS Closure Fast | Active comparator | Procedure: Laser, Procedure: RadiofrequencyPatient with varicose vein treated with VNUS Closure Fast (Radiofrequency System) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
- maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm
Key exclusion criteria (16 listed)
- surgical treatment of the saphenous vein in the past
- sclerotherapy of the saphenous vein in the past
- phlebitis or thrombosis of the saphenous vein
- surgical treatment of an venous ulcer in the past
- postthrombotic syndrome
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 |
|---|---|---|
| LaserEndovenous Laser (1470nm) ablation of great or small saphenous vein | Procedure or surgery | 1470nm Laser, VNUS Closure Fast |
| RadiofrequencyEndovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein | Procedure or surgery | 1470nm Laser, VNUS Closure Fast |
Primary outcome
Pain
Time frame: day 0
Pain (visual analogue scale) on the day of treatment
2 secondary outcomes
Obliteration of the treated vein (GSV or SSV)
Time frame: day 10, month 3, month 12
Patient´s satisfaction after the intervention
Time frame: day 10, month 3, month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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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.
Markus Schreiner principal investigator
2.Chirurgische Abteilung AKh Linz GesmbH
Andreas Shamiyeh study chair
2. Chirurgische Abteilung AKh Linz GesmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laser and Radiofrequency in people with Venous Insufficiency, run by Ludwig Boltzmann Institute for Operative Laparoscopy at 1 site in Austria.
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 2 inclusion and 16 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 30 Oct 2013. 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 Austria. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Markus Schreiner (0043 732 7806 73295, office@chirurgie-schreiner.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: day 0). 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 Oct 2013.