Venous InsufficiencyNCT02588911
Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency
A study testing Conventional Surgery and Radiofrequency Ablation in people with Venous Insufficiency, run by Nelson Wolosker at 1 site in Brazil.
Trial summary
The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs). Read more about this study
- Who is it for?
- Ages 33 to 76 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Conventional Surgery and Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Oct 2015
- 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 33 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 60 years
- Clinical, etiologic, anatomic, pathophysiologic (CEAP): clinical grades 2 to 5 (C2-5), primary (Ep), superficial (As) and reflux only (Pr)
- Duplex scan confirmed primary bilateral GSV insufficiency requiring surgery (insufficiency with reverse venous flow was regarded significant if persisting more than 0.5 seconds in a standing position)
- Duplex scan confirmed suitability for RFA (see exclusion criteria)
- Patients able to give informed consent
Who cannot join
- Varicose veins without GSV insufficiency on duplex scan
- Previous varicose vein surgery
- Associated small saphenous vein reflux, duplication of the GSV at the SFJ, deep venous insufficiency or previous DVT on duplex scan
- GSV diameter <3 mm or >12 mm in the supine position
- Thrombus in the GSV
- Patients with a pacemaker or internal defibrillator
Show all 11Show fewer
- Concomitant peripheral arterial disease (ankle-brachial pressure index of <0.9)
- Patients on oral anticoagulants
- Patients with high blood pressure not controlled by medication
- Patients with known thrombophilia, cancer or lupus
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial of Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency: if You Don't Tell, They Won't Know
The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs).
Read the detailed description
Individuals with symptomatic varicose veins and bilateral GSV insufficiency confirmed by duplex ultrasound examination who were candidates for conventional vein stripping were eligible for inclusion in the study. A total of 18 patients entered the trial. As per protocol, each patient was treated with RFA in one leg and CS on the contralateral limb. Randomisation was performed preoperatively using a randomisation table. Patients were not advised of the treatment allocation in order to ensure that this trial was carried out in a blinded fashion. All operations were performed under regional anaesthesia by the same surgical team, skilled in the management of venous disease with extensive expertise in both techniques. Phlebectomy of varicosities was not concomitantly performed.
The independent observer physician not involved in the original operation, the patient, and the duplex ultrasonographer were not aware of the treatment performed in each case and the surgeon was not involved in outcome assessment.
CS. Patients underwent standard procedure of cranial ligation of the GSV and branches of the sapheno-femoral junction (SFJ) using a groin crease incision and stripping of the GSV from SFJ to ankle level, using a vein stripper that was brought out through a small incision near the medial malleolus.
RFA. The procedure was performed under ultrasound guidance. The GSV proximal to the medial malleolus was cannulated with a 7F sheath using surgical cutdown. The tip of the radiofrequency catheter was placed at least 2 cm distal to the SFJ or just distal to the superficial epigastric vein orifice. Patients received tumescent infiltration with cold normal saline (0.9%) circumferentially around the GSV within its enveloping fascia and along the entire length of the treated vein. This was to prevent nerve injury and thermal injury to the skin. Then the catheter was gradually withdrawn according to the device manufacturer's recommendations. The technique consisted of controlled segmental heating of the GSV, using a catheter with a 7-cm heating element (Closure™ system, VNUS Medical Technologies, Inc., San Jose, California, USA). The temperature was maintained at 120° C per segment using a standard time. The thermoablation continued until the catheter tip reached just below the knee. Immediately following treatment with RFA, intraoperative ultrasound imaging was used to confirm shrinkage of the vein.
For limbs operated with the radiofrequency technique, a groin crease incision was made similar to the contralateral side, but with no manipulation of the SFJ. The incision proximal to the medial malleolus was used for sheath insertion. To ensure that the independent observer physician not involved in the original operation, the patient, and the duplex ultrasonographer were not made aware of the treatment done, both incisions were performed on both legs.
- Conditions
- Venous Insufficiency
- Being tested
- Conventional Surgery, Radiofrequency Ablation
- Keywords
- Radiofrequency Catheter Ablation, Operative Surgical Procedure, Saphenous Vein
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional SurgeryProcedure or surgery
Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein
Radiofrequency AblationProcedure or surgery
Catheter-based ablation of the great saphenous vein
| Study group | Role | What they receive |
|---|---|---|
| Conventional Surgery | Active comparator | Limb with GSV insufficiency in the same patient, randomised to conventional surgery Receives: Procedure: Conventional Surgery |
| Radiofrequency Ablation | Active comparator | Limb with GSV insufficiency in the same patient, randomised to radiofrequency ablation Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of hyper pigmentation using a scale of 0 to 10
Patients and physicians were oriented to indicate their subjective perception of intensity of hyperpigmentation on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).
Measured: One week, one month and six months after surgery
Change in extension of hematoma using a scale of 0 to 10
Patients and physicians were oriented to indicate their subjective perception of extension of hematoma on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).
Measured: One week, one month and six months after surgery
Change in aesthetic results using a scale of 0 to 10
Patients and physicians were oriented to indicate their subjective perception of aesthetic results on a scale of 0 (unaesthetic) to 10 (excellent results).
Measured: One week, one month and six months after surgery
Change in pain levels using a scale of 0 to 10
Patients were asked to indicate pain levels on a scale of 0 (no pain) to 10 (worst imaginable pain).
Measured: One week, one month and six months after surgery
Change in intensity of skin burns using a scale of 0 to 10
Physicians were asked to inform intensity of skin burns on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).
Measured: One week, one month and six months after surgery
Change in presence of sensitivity alteration
Patients were asked to indicate the presence or absence of sensitivity alteration.
Measured: One week, one month and six months after surgery
Change in presence of thrombophlebitis
Physicians were asked to inform the presence or absence of thrombophlebitis.
Measured: One week, one month and six months after surgery
Change in presence of resection or occlusion of the great saphenous vein
Duplex ultrasound scan was used to evaluate the presence or absence of resection or occlusion (success rate) of the great saphenous vein.
Measured: One month, six months and 12 months after surgery
Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein
Duplex ultrasound scan was used to evaluate the presence or absence of reflux in the sapheno-femoral junction and in the great saphenous vein
Measured: One month, six months and 12 months after surgery
Change in presence of complications
Duplex ultrasound scan was used to evaluate the presence or absence of complications such as deep vein thrombosis (DVT) and lymphocele.
Measured: One month, six months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nelson Wolosker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nelson Wolosker, Hospital Israelita Albert Einstein
- Investigators
- Nelson Wolosker, MD, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588911
- Sponsor's protocol ID
- RFA vs CS
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers, De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015 Jun;49(6):678-737. doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25. No abstract available.
PubMed 25920631Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.
PubMed 22705163Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD. A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg. 2006 Feb;31(2):212-8. doi: 10.1016/j.ejvs.2005.07.005. Epub 2005 Aug 31.
PubMed 16137898Goode SD, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD. Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm). Eur J Vasc Endovasc Surg. 2010 Aug;40(2):246-53. doi: 10.1016/j.ejvs.2010.02.026.
PubMed 20537570Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg. 2010 Jan;39(1):104-11. doi: 10.1016/j.ejvs.2009.09.012. Epub 2009 Oct 29.
PubMed 19879166Mendes CA, Martins AA, Fukuda JM, Parente JB, Munia MA, Fioranelli A, Teivelis MP, Varella AY, Caffaro RA, Kuzniec S, Wolosker N. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know. Clinics (Sao Paulo). 2016 Nov 1;71(11):650-656. doi: 10.6061/clinics/2016(11)06.
PubMed 27982166
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency: if You Don't Tell, They Won't Know
- ClinicalTrials.gov ID
- NCT02588911
- Acronym / sponsor ID
- RFA vs CS
- Conditions
- Venous Insufficiency
- Keywords
- Radiofrequency Catheter Ablation, Operative Surgical Procedure, Saphenous Vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nelson WoloskerUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Oct 2015 (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.
The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs).
Detailed description
Individuals with symptomatic varicose veins and bilateral GSV insufficiency confirmed by duplex ultrasound examination who were candidates for conventional vein stripping were eligible for inclusion in the study. A total of 18 patients entered the trial. As per protocol, each patient was treated with RFA in one leg and CS on the contralateral limb. Randomisation was performed preoperatively using a randomisation table. Patients were not advised of the treatment allocation in order to ensure that this trial was carried out in a blinded fashion. All operations were performed under regional anaesthesia by the same surgical team, skilled in the management of venous disease with extensive expertise in both techniques. Phlebectomy of varicosities was not concomitantly performed.
The independent observer physician not involved in the original operation, the patient, and the duplex ultrasonographer were not aware of the treatment performed in each case and the surgeon was not involved in outcome assessment.
CS. Patients underwent standard procedure of cranial ligation of the GSV and branches of the sapheno-femoral junction (SFJ) using a groin crease incision and stripping of the GSV from SFJ to ankle level, using a vein stripper that was brought out through a small incision near the medial malleolus.
RFA. The procedure was performed under ultrasound guidance. The GSV proximal to the medial malleolus was cannulated with a 7F sheath using surgical cutdown. The tip of the radiofrequency catheter was placed at least 2 cm distal to the SFJ or just distal to the superficial epigastric vein orifice. Patients received tumescent infiltration with cold normal saline (0.9%) circumferentially around the GSV within its enveloping fascia and along the entire length of the treated vein. This was to prevent nerve injury and thermal injury to the skin. Then the catheter was gradually withdrawn according to the device manufacturer's recommendations. The technique consisted of controlled segmental heating of the GSV, using a catheter with a 7-cm heating element (Closure™ system, VNUS Medical Technologies, Inc., San Jose, California, USA). The temperature was maintained at 120° C per segment using a standard time. The thermoablation continued until the catheter tip reached just below the knee. Immediately following treatment with RFA, intraoperative ultrasound imaging was used to confirm shrinkage of the vein.
For limbs operated with the radiofrequency technique, a groin crease incision was made similar to the contralateral side, but with no manipulation of the SFJ. The incision proximal to the medial malleolus was used for sheath insertion. To ensure that the independent observer physician not involved in the original operation, the patient, and the duplex ultrasonographer were not made aware of the treatment done, both incisions were performed on both legs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgery | Active comparator | Procedure: Conventional SurgeryLimb with GSV insufficiency in the same patient, randomised to conventional surgery |
| Radiofrequency Ablation | Active comparator | Procedure: Radiofrequency AblationLimb with GSV insufficiency in the same patient, randomised to radiofrequency ablation |
Who may qualify
- Ages
- 33 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years
- Clinical, etiologic, anatomic, pathophysiologic (CEAP): clinical grades 2 to 5 (C2-5), primary (Ep), superficial (As) and reflux only (Pr)
- Duplex scan confirmed primary bilateral GSV insufficiency requiring surgery (insufficiency with reverse venous flow was regarded significant if persisting more than 0.5 seconds in a standing position)
- Duplex scan confirmed suitability for RFA (see exclusion criteria)
- Patients able to give informed consent
Key exclusion criteria (11 listed)
- Varicose veins without GSV insufficiency on duplex scan
- Previous varicose vein surgery
- Associated small saphenous vein reflux, duplication of the GSV at the SFJ, deep venous insufficiency or previous DVT on duplex scan
- GSV diameter <3 mm or >12 mm in the supine position
- Thrombus in the GSV
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 |
|---|---|---|
| Conventional SurgeryCranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein | Procedure or surgery | Conventional Surgery |
| Radiofrequency AblationCatheter-based ablation of the great saphenous vein | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Change in intensity of hyper pigmentation using a scale of 0 to 10
Time frame: One week, one month and six months after surgery
Patients and physicians were oriented to indicate their subjective perception of intensity of hyperpigmentation on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).
Change in extension of hematoma using a scale of 0 to 10
Time frame: One week, one month and six months after surgery
Patients and physicians were oriented to indicate their subjective perception of extension of hematoma on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).
Change in aesthetic results using a scale of 0 to 10
Time frame: One week, one month and six months after surgery
Patients and physicians were oriented to indicate their subjective perception of aesthetic results on a scale of 0 (unaesthetic) to 10 (excellent results).
Change in pain levels using a scale of 0 to 10
Time frame: One week, one month and six months after surgery
Patients were asked to indicate pain levels on a scale of 0 (no pain) to 10 (worst imaginable pain).
Change in intensity of skin burns using a scale of 0 to 10
Time frame: One week, one month and six months after surgery
Physicians were asked to inform intensity of skin burns on a scale of 0 (no complaint/discomfort) to 10 (maximal complaint/discomfort).
Change in presence of sensitivity alteration
Time frame: One week, one month and six months after surgery
Patients were asked to indicate the presence or absence of sensitivity alteration.
Change in presence of thrombophlebitis
Time frame: One week, one month and six months after surgery
Physicians were asked to inform the presence or absence of thrombophlebitis.
Change in presence of resection or occlusion of the great saphenous vein
Time frame: One month, six months and 12 months after surgery
Duplex ultrasound scan was used to evaluate the presence or absence of resection or occlusion (success rate) of the great saphenous vein.
Change in presence of reflux in the sapheno-femoral junction and in the great saphenous vein
Time frame: One month, six months and 12 months after surgery
Duplex ultrasound scan was used to evaluate the presence or absence of reflux in the sapheno-femoral junction and in the great saphenous vein
Change in presence of complications
Time frame: One month, six months and 12 months after surgery
Duplex ultrasound scan was used to evaluate the presence or absence of complications such as deep vein thrombosis (DVT) and lymphocele.
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 28 Oct 2015.
- Background: PubMed 25920631Wittens C, Davies AH, Baekgaard N, Broholm R, Cavezzi A, Chastanet S, de Wolf M, Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Koncar I, Lindholt J, de Ceniga MV, Vermassen F, Verzini F, Document Reviewers, De Maeseneer MG, Blomgren L, Hartung O, Kalodiki E, Korten E, Lugli M, Naylor R, Nicolini P, Rosales A. Editor's Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2015 Jun;49(6):678-737. doi: 10.1016/j.ejvs.2015.02.007. Epub 2015 Apr 25. No abstract available.
- Background: PubMed 22705163Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.
- Background: PubMed 16137898Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD. A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins. Eur J Vasc Endovasc Surg. 2006 Feb;31(2):212-8. doi: 10.1016/j.ejvs.2005.07.005. Epub 2005 Aug 31.
- Background: PubMed 20537570Goode SD, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD. Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm). Eur J Vasc Endovasc Surg. 2010 Aug;40(2):246-53. doi: 10.1016/j.ejvs.2010.02.026.
- Background: PubMed 19879166Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg. 2010 Jan;39(1):104-11. doi: 10.1016/j.ejvs.2009.09.012. Epub 2009 Oct 29.
- Derived from this study: PubMed 27982166Mendes CA, Martins AA, Fukuda JM, Parente JB, Munia MA, Fioranelli A, Teivelis MP, Varella AY, Caffaro RA, Kuzniec S, Wolosker N. Randomized trial of radiofrequency ablation versus conventional surgery for superficial venous insufficiency: if you don't tell, they won't know. Clinics (Sao Paulo). 2016 Nov 1;71(11):650-656. doi: 10.6061/clinics/2016(11)06.
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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.
Nelson Wolosker, MD, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Surgery and Radiofrequency Ablation in people with Venous Insufficiency, run by Nelson Wolosker at 1 site in Brazil.
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 5 inclusion and 11 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 28 Oct 2015. 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 Brazil. 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?
Change in intensity of hyper pigmentation using a scale of 0 to 10 (time frame: One week, one month and six months after surgery). The study lists 10 primary outcomes in all. 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 NCT02588911, which also lists 6 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 Oct 2015.