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- Varisolve (polidocanol endovenous microfoam) / Boston Scientific
[VIRTUAL] Tips, Tricks And Limitations: Varithena (Trianon Ballroom, 3rd Floor) - Nov 19, 2020 - Abstract #VEITH2020VEITH_355;
- Varisolve (polidocanol endovenous microfoam) / Boston Scientific, Asclera (polidocanol) / Merz Pharma
[VIRTUAL] Varithena® VLU Registry: The Effects Of Polidocanol Endovenous Microfoam On Wound Healing And Recurrence (Trianon Ballroom, 3rd Floor) - Nov 19, 2020 - Abstract #VEITH2020VEITH_269;
- | Varisolve (polidocanol endovenous microfoam) / Boston Scientific, Asclera (polidocanol) / Merz Pharma
Preclinical, Journal: In vitro and ex vivo evaluation of the biological performance of sclerosing foams. (Pubmed Central) - Oct 27, 2020
In our series of comparisons, PEM presented a greater overall efficacy compared to PCFs, across the different biological models, which was attributed to its drainage dynamics and gas formulation. This is consistent with earlier studies that indicated superior physical cohesiveness of PEM compared to PCFs.
- Varisolve (polidocanol endovenous microfoam) / Boston Scientific, Asclera (polidocanol) / Merz Pharma
[VIRTUAL] Ultrasound Assessment of Endothermal Ablation with or without Polidocanol Endovenous Microfoam Therapy in Patients with Chronic Venous Disease: A Retrospective Study (Washington) - Oct 26, 2020 - Abstract #AVLS2020AVLS_153;
Patients in the RFA/PEM group achieved similar closure rates when compared with the RFA only group in terms of closure at 1 week (97.0% vs. 96.0% p=1.000). Patients in the RFA/PEM group also showed similar outcomes when compared with RFA only group in in terms of closure at 6 months (87.5% vs 89.3% p=0.7680) and residual reflux at the distal GSV (42.9% vs 44.6% p=0.8489).
- | Varithena (polidocanol injectable foam) / Boston Scientific
Trial completion, Trial completion date, Trial primary completion date: Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease (clinicaltrials.gov) - Aug 21, 2020
P2, N=120, Completed, Sponsor: Universidade do Porto
Patients in the RFA/PEM group also showed similar outcomes when compared with RFA only group in in terms of closure at 6 months (87.5% vs 89.3% p=0.7680) and residual reflux at the distal GSV (42.9% vs 44.6% p=0.8489). Recruiting --> Completed | Trial completion date: Oct 2020 --> Jul 2020 | Trial primary completion date: Oct 2020 --> Jul 2020
- || Varithena (polidocanol injectable foam) / Boston Scientific
Enrollment closed, Enrollment change: VIEW-VLU: Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU) (clinicaltrials.gov) - May 4, 2020
P=N/A, N=82, Active, not recruiting, Sponsor: Provensis Ltd
Recruiting --> Completed | Trial completion date: Oct 2020 --> Jul 2020 | Trial primary completion date: Oct 2020 --> Jul 2020 Recruiting --> Active, not recruiting | N=200 --> 82
- | Varithena (polidocanol injectable foam) / Boston Scientific
New P2 trial: Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease (clinicaltrials.gov) - Sep 17, 2019
P2, N=120, Recruiting, Sponsor: Universidade do Porto
- | Varithena (polidocanol endovenous microfoam) / Boston Scientific, Asclera (polidocanol) / Merz Pharma
Clinical, Journal: Use of Polidocanol endovenous microfoam to improve hemodynamics and symptomology in patients with challenging clinical presentations: A case series. (Pubmed Central) - Dec 13, 2018
Recruiting --> Active, not recruiting | N=200 --> 82 PEM use in C3-C6 patients resulted in successful improvement in VCSS, CVI symptoms, and wound healing among patients in whom ETA was not considered to be the optimal therapy.
- | Varithena (polidocanol endovenous microfoam) / Boston Scientific, Asclera (polidocanol) / Merz Pharma
Clinical, Journal: Relationship between patient-reported symptoms, limitations in daily activities, and psychological impact in varicose veins. (Pubmed Central) - Jul 18, 2018
Symptoms and functional limitations led to greater psychological impact. Physicians should routinely ascertain symptoms and functional limitations to enhance quality of care and to document medical necessity.
- | Varithena (polidocanol injectable foam) / Boston Scientific
Enrollment open, Trial completion date, Trial primary completion date: VIEW-VLU: Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU) (clinicaltrials.gov) - Apr 18, 2018
P=N/A, N=200, Recruiting, Sponsor: Provensis Ltd
Physicians should routinely ascertain symptoms and functional limitations to enhance quality of care and to document medical necessity. Not yet recruiting --> Recruiting | Trial completion date: Dec 2019 --> Jul 2021 | Trial primary completion date: Jul 2019 --> Jul 2020
- | Varithena (polidocanol endovenous microfoam) / Boston Scientific, Asclera (polidocanol) / Merz Pharma
Clinical, Journal: Improvement in patient-reported outcomes of varicose veins following treatment with polidocanol endovenous microfoam. (Pubmed Central) - Mar 7, 2018
Conclusions Patients with above-average symptom improvement had better functional and psychological improvement. PEM 1% treatment had higher odds of clinically meaningful functional and psychological improvement.
- | Varithena (polidocanol injectable foam) / Boston Scientific
Enrollment change, Trial withdrawal, Trial primary completion date: Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs (clinicaltrials.gov) - Sep 15, 2017
P4, N=0, Withdrawn, Sponsor: OhioHealth
PEM 1% treatment had higher odds of clinically meaningful functional and psychological improvement. N=60 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Apr 2018 --> Sep 2017
- | Varithena (polidocanol injectable foam) / Boston Scientific
New trial: VIEW-VLU: Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU) (clinicaltrials.gov) - Aug 22, 2017
P=N/A, N=200, Not yet recruiting, Sponsor: Provensis Ltd
- | Varithena (polidocanol endovenous microfoam) / Boston Scientific
Journal: A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. (Pubmed Central) - Jul 26, 2017
P3
In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%) Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833).
- | Varithena (polidocanol endovenous microfoam) / Boston Scientific
Journal: A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. (Pubmed Central) - Jul 5, 2017
P2/3
Adverse events were generally mild and transient. (www.clinicaltrials.gov [NCT00758420]).
- | Varithena (polidocanol injectable foam) / Boston Scientific
Enrollment open, Phase classification: Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs (clinicaltrials.gov) - Apr 4, 2017
P4, N=60, Recruiting, Sponsor: OhioHealth
(www.clinicaltrials.gov [NCT00758420]). Not yet recruiting --> Recruiting | Phase classification: PN/A --> P4
- Varithena (polidocanol injectable foam) / Boston Scientific
New trial: Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs (clinicaltrials.gov) - Dec 9, 2016
P=N/A, N=60, Not yet recruiting, Sponsor: OhioHealth
- Asclera (polidocanol) / Merz Pharma
Trial completion: PG3T: Polidocanol Versus Glucose Treatment of Telangiectasia Trial (clinicaltrials.gov) - Dec 1, 2016
P4, N=115, Completed, Sponsor: UPECLIN HC FM Botucatu Unesp
Not yet recruiting --> Recruiting | Phase classification: PN/A --> P4 Recruiting --> Completed
- Asclera (polidocanol) / Merz Pharma
Enrollment open, Trial primary completion date: PG3T: Polidocanol Versus Glucose Treatment of Telangiectasia Trial (clinicaltrials.gov) - May 26, 2016
P4, N=115, Recruiting, Sponsor: UPECLIN HC FM Botucatu Unesp
Recruiting --> Completed Active, not recruiting --> Recruiting | Trial primary completion date: Apr 2016 --> Sep 2016
- Varithena (polidocanol injectable foam) / Boston Scientific
Trial completion, Trial primary completion date: COMFORT: A Multicenter, Open-label, Randomized, Crossover Study (clinicaltrials.gov) - Mar 10, 2016
P4, N=36, Completed, Sponsor: BTG International Inc.
Active, not recruiting --> Recruiting | Trial primary completion date: Apr 2016 --> Sep 2016 Active, not recruiting --> Completed | Trial primary completion date: Jun 2016 --> Dec 2015
- Varithena (polidocanol injectable foam) / Boston Scientific
Trial primary completion date: COMFORT: A Multicenter, Open-label, Randomized, Crossover Study (clinicaltrials.gov) - Mar 2, 2016
P4, N=34, Active, not recruiting, Sponsor: BTG International Inc.
Active, not recruiting --> Completed | Trial primary completion date: Jun 2016 --> Dec 2015 Trial primary completion date: Jan 2016 --> Jun 2016
- | Asclera (polidocanol) / Merz Pharma
New P4 trial: PG3T: Polidocanol Versus Glucose Treatment of Telangiectasia Trial (clinicaltrials.gov) - Jan 15, 2016
P4, N=115, Active, not recruiting, Sponsor: UPECLIN HC FM Botucatu Unesp
- Varithena (polidocanol injectable foam) / Boston Scientific
Enrollment closed: COMFORT: A Multicenter, Open-label, Randomized, Crossover Study (clinicaltrials.gov) - Oct 28, 2015
P4, N=34, Active, not recruiting, Sponsor: BTG International Inc.
Trial primary completion date: Jan 2016 --> Jun 2016 Recruiting --> Active, not recruiting
- Varithena (polidocanol injectable foam) / Boston Scientific
New P4 trial: COMFORT: A Multicenter, Open-label, Randomized, Crossover Study (clinicaltrials.gov) - Jun 4, 2015
P4, N=34, Recruiting, Sponsor: BTG International Inc.
- Varithena (polidocanol injectable foam) / Boston Scientific
Trial primary completion date: VANISH-2: Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (clinicaltrials.gov) - Mar 12, 2015
P3, N=235, Completed, Sponsor: BTG International Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2012 --> Sep 2011
- Varithena (polidocanol injectable foam) / Boston Scientific
Trial primary completion date: VANISH-1: Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (clinicaltrials.gov) - Mar 10, 2015
P3, N=279, Completed, Sponsor: BTG International Inc.
Trial primary completion date: Jan 2012 --> Sep 2011 Trial primary completion date: Apr 2012 --> Dec 2011
- | Asclera (polidocanol) / Merz Pharma
New P4 trial: Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins (clinicaltrials.gov) - Feb 2, 2014
P4, N=100, Recruiting, Sponsor: UPECLIN HC FM Botucatu Unesp
- Varithena (polidocanol injectable foam) / Boston Scientific
Enrollment change: Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt (clinicaltrials.gov) - Jan 6, 2014
P2, N=60, Completed, Sponsor: BTG International Inc.
Trial primary completion date: Apr 2012 --> Dec 2011 N=83 --> 60
- | Varithena (polidocanol injectable foam) / Boston Scientific
Trial completion: VANISH-2: Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (clinicaltrials.gov) - Mar 6, 2013
P3, N=228, Completed, Sponsor: BTG Ltd.
N=83 --> 60 Active, not recruiting --> Completed
- | Varithena (polidocanol injectable foam) / Boston Scientific
Trial completion: VAP.VV017: Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (clinicaltrials.gov) - Mar 6, 2013
P3, N=105, Completed, Sponsor: BTG Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Varithena (polidocanol injectable foam) / Boston Scientific
Trial completion: VANISH-1: Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (clinicaltrials.gov) - Mar 6, 2013
P3, N=250, Completed, Sponsor: BTG Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Varithena (polidocanol injectable foam) / Boston Scientific
Trial completion: Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM) (clinicaltrials.gov) - Mar 6, 2013
P1, N=21, Completed, Sponsor: BTG International Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Varithena (polidocanol injectable foam) / Boston Scientific
New P1 trial: Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM) (clinicaltrials.gov) - Aug 31, 2011
P1, N=21, Completed, Sponsor: BTG International Inc.