Trial · NCT01197833
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
NCT01197833, Phase 3, Completed, Boston Scientific Corporation; results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities. Trials, record NCT01197833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01197833
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
- NCT number
- NCT01197833
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Great Saphenous Vein Incompetence, Visible Varicosities
- Interventions
- endovenous ablation+polidocanol injectable microfoam 0.125%, Endovenous ablation+polidocanol injectable microfoam 1.0%, Endovenous ablation+polidocanol injectable foam 2.0%
- First posted
- 2010-09-09
- Last updated
- 2021-04-21
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | IPR-V3 measured at baseline and then at 8 weeks | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins. |
| Primary | Absolute Change From Baseline in PA-V3 Score | PA-V3 measured at baseline and then at 8 weeks | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | IPR-V3 measured at baseline and then at 8 weeks | score | LEAST_SQUARES_MEAN | |
| PRIMARY | Absolute Change From Baseline in PA-V3 Score | PA-V3 measured at baseline and then at 8 weeks | score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | Endovenous Ablation, Vehicle Placebo | -0.80 | Standard Error 0.102 | score | |
| Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | -1.30 | Standard Error 0.100 | score | |
| Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score) | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | -1.11 | Standard Error 0.097 | score | |
| Absolute Change From Baseline in PA-V3 Score | Endovenous Ablation, Vehicle Placebo | -1.59 | Standard Error 0.142 | score | |
| Absolute Change From Baseline in PA-V3 Score | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | -1.81 | Standard Error 0.140 | score | |
| Absolute Change From Baseline in PA-V3 Score | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | -1.85 | Standard Error 0.136 | score |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Endovenous Ablation, Vehicle Placebo | 38 | |
| Overall Study | STARTED | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 39 | |
| Overall Study | STARTED | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 40 | |
| Overall Study | COMPLETED | Endovenous Ablation, Vehicle Placebo | 38 | |
| Overall Study | COMPLETED | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 39 | |
| Overall Study | COMPLETED | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 40 | |
| Overall Study | NOT COMPLETED | Endovenous Ablation, Vehicle Placebo | 0 | |
| Overall Study | NOT COMPLETED | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 0 | |
| Overall Study | NOT COMPLETED | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 0 |
Source ClinicalTrials.gov
Adverse events48
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 | Endovenous Ablation, Vehicle Placebo | 1 | 38 | 1 |
| other | extravasation | General disorders | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 3 | 39 | 3 |
| other | extravasation | General disorders | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 2 | 40 | 2 |
| other | infusion site thrombosis | General disorders | Endovenous Ablation, Vehicle Placebo | 0 | 38 | 0 |
| other | infusion site thrombosis | General disorders | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 3 | 39 | 3 |
| other | infusion site thrombosis | General disorders | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 3 | 40 | 3 |
| other | edema peripheral | General disorders | Endovenous Ablation, Vehicle Placebo | 0 | 38 | 0 |
| other | edema peripheral | General disorders | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 1 | 39 | 1 |
| other | edema peripheral | General disorders | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 4 | 40 | 4 |
| other | tenderness | General disorders | Endovenous Ablation, Vehicle Placebo | 0 | 38 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Endovenous Ablation, Vehicle Placebo | ||
| Total, all-cause mortality | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | ||
| Total, all-cause mortality | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | ||
| Total, other adverse events | Endovenous Ablation, Vehicle Placebo | 20 | 38 |
| Total, other adverse events | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 29 | 39 |
| Total, other adverse events | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 35 | 40 |
| Total, serious adverse events | Endovenous Ablation, Vehicle Placebo | 0 | 38 |
| Total, serious adverse events | Endovenous Ablation, Polidocanol Injectable Foam, 0.5% | 0 | 39 |
| Total, serious adverse events | Endovenous Ablation, Polidocanol Injectable Foam 1.0% | 0 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26957489 | DERIVED |
Source PubMed
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/NCT01197833
GET https://conductscience.org/api/trials/v1/NCT01197833/events?page=2