Trial · NCT00928421
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
NCT00928421, Phase 2, Completed, Boston Scientific Corporation; results first posted 2014-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins. Trials, record NCT00928421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00928421
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
- NCT number
- NCT00928421
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Varicose Veins
- Interventions
- Polidocanol Endovenous Microfoam 0.125%
- First posted
- 2009-06-26
- Last updated
- 2021-05-13
- Results first posted
- 2014-04-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responders to Treatment, Assessed by Duplex Ultrasound | 8 weeks | Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Responders to Treatment, Assessed by Duplex Ultrasound | 8 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responders to Treatment, Assessed by Duplex Ultrasound | Polidocanol Injectable Foam 0.125% | 9 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Polidocanol Injectable Foam 0.125% | 16 | |
| Overall Study | Treated With Study Drug | Polidocanol Injectable Foam 0.125% | 16 | |
| Overall Study | COMPLETED | Polidocanol Injectable Foam 0.125% | 16 | |
| Overall Study | NOT COMPLETED | Polidocanol Injectable Foam 0.125% | 0 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | extravasation | General disorders | Polidocanol Injectable Foam 0.125% | 1 | 16 | 1 |
| other | local swelling | General disorders | Polidocanol Injectable Foam 0.125% | 2 | 16 | 2 |
| other | limb discomfort | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam 0.125% | 8 | 16 | 8 |
| other | muscle spasms | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam 0.125% | 1 | 16 | 1 |
| other | pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam 0.125% | 2 | 16 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Polidocanol Injectable Foam 0.125% | ||
| Total, other adverse events | Polidocanol Injectable Foam 0.125% | 9 | 16 |
| Total, serious adverse events | Polidocanol Injectable Foam 0.125% | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00928421
GET https://conductscience.org/api/trials/v1/NCT00928421/registered