VaricosisClariVein-2NCT01459263
Early Outcome of Mechanochemical Endovenous Ablation
An observational study of Varicosis, run by Rijnstate Hospital at 2 sites in Netherlands.
Trial summary
More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Varicosis
- What is being tested?
- ClariVein
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2010to Feb 2018
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with insufficiency of the greater saphenous vein will be included.
Who may be able to join
- Insufficiency of the GSV
- Ultrasound criteria for endovenous treatment have been met:
- Diameter GSV between 3-12 mm
- No thrombus present at the GSV part to be treated
- Signed informed consent
- Patient willing to present at follow-up visits
- Age > 18 jaar
Who cannot join
- Patient is unable to give informed consent
- Patient unable to present at all follow-up visits
- Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
- Pregnancy and breast feeding
- Known allergy/ contra indication for sclerotherapy
- Previous ipsilateral surgical treatment of varicose veins
- Deep venous vein thrombosis in medical history
- Anticoagulant therapy
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem, Gelderland
St. Antonius Hospital
Nieuwegein
About this study
Official title: Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.
- Conditions
- Varicosis
- Being tested
- ClariVein
- Keywords
- GSV, insufficiency, ClariVein device, safety, efficacy, QOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariVeinDevice
Using the ClariVein device, the GSV will be occluded.
| Study group | Role | What they receive |
|---|---|---|
| GSV insufficiency | Patients with insufficiency of the greater saphenous vein (GSV) will be included. Receives: Device: ClariVein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion rate
The percentage of GSV occluded
Measured: 30 days, 1, 2, and 5 years
Secondary outcomes (7)
Health status
Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points.
The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
Measured: 30 days, 1, 2, and 5 years
Disease related quality of life
Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.
Measured: 30 days, 1, 2, and 5 years
Pain score during procedure
The pain will be scored during procedure using the VAS score.
Measured: peri-procedural
2-weeks post-procedure pain score
The pain will be scored daily for two weeks after the procedure using the VAS score.
Measured: two weeks
recovery time
The time (in days) after the procedure until patients were able to restart daily activity/daily work
Measured: two weeks
procedural complications
all complications related to the procedure will be evaluated at the mentioned time points.
Measured: during procedure
post-procedural complications
all complications related to the procedure will be evaluated at the mentioned time points.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VaricosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel MJ Reijnen, MD, PhD, Principal investigator, Rijnstate HospitalJean-Paul Vries, de, MD, Phd, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459263
- Sponsor's protocol ID
- NL26327.091.09
- Acronym
- ClariVein-2
- Status last verified
- Apr 2018
- First submitted
- 8 Aug 2011
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1.
PubMed 21679070van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch.
PubMed 21854655van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8.
PubMed 23141679Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9.
PubMed 23312507
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
- ClinicalTrials.gov ID
- NCT01459263
- Acronym / sponsor ID
- ClariVein-2 / NL26327.091.09
- Conditions
- Varicosis
- Keywords
- GSV, insufficiency, ClariVein device, safety, efficacy, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- St. Antonius Hospital
- Study start
- Nov 2010
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Oct 2011 (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.
More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSV insufficiency | – | Device: ClariVeinPatients with insufficiency of the greater saphenous vein (GSV) will be included. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with insufficiency of the greater saphenous vein will be included.
Key inclusion criteria (7 listed)
- Insufficiency of the GSV
- Ultrasound criteria for endovenous treatment have been met:
- Diameter GSV between 3-12 mm
- No thrombus present at the GSV part to be treated
- Signed informed consent
Key exclusion criteria (8 listed)
- Patient is unable to give informed consent
- Patient unable to present at all follow-up visits
- Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
- Pregnancy and breast feeding
- Known allergy/ contra indication for sclerotherapy
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 |
|---|---|---|
| ClariVeinUsing the ClariVein device, the GSV will be occluded. | Device | GSV insufficiency |
Primary outcome
Occlusion rate
Time frame: 30 days, 1, 2, and 5 years
The percentage of GSV occluded
7 secondary outcomes
Health status
Time frame: 30 days, 1, 2, and 5 years
Disease related quality of life
Time frame: 30 days, 1, 2, and 5 years
Pain score during procedure
Time frame: peri-procedural
2-weeks post-procedure pain score
Time frame: two weeks
recovery time
Time frame: two weeks
procedural complications
Time frame: during procedure
post-procedural complications
Time frame: 1 year
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 26 Apr 2018.
- Results publication: PubMed 21679070van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1.
- Results publication: PubMed 21854655van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch.
- Results publication: PubMed 23141679van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8.
- Results publication: PubMed 23312507Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9.
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.
Michel MJ Reijnen, MD, PhD principal investigator
Rijnstate Hospital
Jean-Paul Vries, de, MD, Phd principal investigator
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicosis, run by Rijnstate Hospital at 2 sites in Netherlands.
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 7 inclusion and 8 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 26 Apr 2018. 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 Netherlands. 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?
Occlusion rate (time frame: 30 days, 1, 2, and 5 years). 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 NCT01459263, which also lists 4 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 26 Apr 2018.