A Phase 4 interventional study of Varithena® and Radiofrequency ablation in Varicose Veins, sponsored by Boston Scientific Corporation. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by Boston Scientific Corporation · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate pain the patient experienced following treatment of varicose veins with Varithena® compared to radiofrequency ablation.
A study that evaluates pain following treatment of varicose veins in patients treated with Varithena® and those treated with RFA.
253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.
This study's enrollment of 35 is below the median of 104 across 162 interventional studies indexed under Varicose Veins.
Browse Varicose Veins studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindications to Varithena® (e.g., acute thromboembolic disease) or RFA according to the manufacturer's prescribing information
Varithena (polidocanol injectable foam) supplied as polidocanol solution 180 mg/18 mL (10 mg/mL) to be activated before use. Once activated, Varithena is a white injectable foam delivering a 1% polidocanol solution. Each milliliter of Varithena injectable foam contains 1.3 mg of polidocanol. Up to 5 mL per injection or 15 mL per treatment session could be used. This was followed by RFA treatment.
Drug: Varithena® · Device: Radiofrequency ablation
RFA procedures were conducted in accordance with the physician's standard of care and according to the manufacturer's instructions for use. This was followed by treatment with Varithena.
Drug: Varithena® · Device: Radiofrequency ablation
Varithena® treatment in accordance with full prescribing information and instructions for use
Also known as: Polidocanol Solution, 180 mg/18 mL (10 mg/mL)
Radiofrequency ablation conducted per physicians' standard of care.
Also known as: RFA
Pain
14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.
Time frame: 14 day average (0-100)
Procedural Pain
degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine
Time frame: immediately following procedure
Patient Preference
Patient preference for RFA or Varithena® using e-diary
Time frame: 8 weeks
| Milestone | Varithena® First Then Radiofrequency Ablation | Radiofrequency Ablation First Than Varithena |
|---|---|---|
| Started | 18 | 17 |
| Completed | 18 | 17 |
| Not completed | 0 | 0 |
| Milestone | Varithena® First Then Radiofrequency Ablation | Radiofrequency Ablation First Than Varithena |
|---|---|---|
| Started | 18 | 17 |
| Completed | 17 | 16 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.
| units on a scale | Varithena® | Radiofrequency Ablation |
|---|---|---|
| Pain | 11.3 ± 2.90 | 9.5 ± 2.90 |
degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine
| units on a scale | Varithena® | Radiofrequency Ablation |
|---|---|---|
| Procedural Pain | 16.4 ± 3.53 | 17.8 ± 3.53 |
Patient preference for RFA or Varithena® using e-diary
| Participants | Varithena® | Radiofrequency Ablation |
|---|---|---|
| Patient Preference | 19 | 14 |
Collected over A period of time ending at Week 4 (day 32). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varithena® | 0/34 (0%) | 0/34 (0%) | 4/34 (11.8%) |
| Radiofrequency Ablation | 0/34 (0%) | 0/34 (0%) | 3/34 (8.8%) |
| Event | Varithena® | Radiofrequency Ablation |
|---|---|---|
| PhlebitisVascular disorders | 3/34 | 1/34 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/34 | 2/34 |
| Age, Continuous(years) | Varithena® |
|---|---|
| Mean | 50.9 ± 11.86 |
| Sex: Female, Male(Participants) | Varithena® |
|---|---|
| Female | 25 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Varithena® |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Plan to share: No
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