Trial · NCT02462720
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
NCT02462720, Phase 4, Completed, Boston Scientific Corporation; results first posted 2018-01-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COMFORT: A Multicenter, Open-label, Randomized, Crossover Study. Trials, record NCT02462720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02462720
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COMFORT: A Multicenter, Open-label, Randomized, Crossover Study
- NCT number
- NCT02462720
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 35 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Varicose Veins
- Interventions
- Varithena®, Radiofrequency ablation
- First posted
- 2015-06-04
- Last updated
- 2021-04-21
- Results first posted
- 2018-01-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain | 14 day average (0-100) | 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. |
| Secondary | Procedural Pain | immediately following procedure | 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 |
| Secondary | Patient Preference | 8 weeks | Patient preference for RFA or Varithena® using e-diary |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain | 14 day average (0-100) | units on a scale | MEAN | |
| SECONDARY | Procedural Pain | immediately following procedure | units on a scale | MEAN | |
| SECONDARY | Patient Preference | 8 weeks | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Pain | Varithena® | 11.3 | Standard Error 2.90 | units on a scale | |
| Pain | Radiofrequency Ablation | 9.5 | Standard Error 2.90 | units on a scale | |
| Procedural Pain | Varithena® | 16.4 | Standard Error 3.53 | units on a scale | |
| Procedural Pain | Radiofrequency Ablation | 17.8 | Standard Error 3.53 | units on a scale | |
| Patient Preference | Varithena® | 19 | Participants | ||
| Patient Preference | Radiofrequency Ablation | 14 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Varithena® First Then Radiofrequency Ablation | 18 | |
| Part 1 | STARTED | Radiofrequency Ablation First Than Varithena | 17 | |
| Part 1 | COMPLETED | Varithena® First Then Radiofrequency Ablation | 18 | |
| Part 1 | COMPLETED | Radiofrequency Ablation First Than Varithena | 17 | |
| Part 1 | NOT COMPLETED | Varithena® First Then Radiofrequency Ablation | 0 | |
| Part 1 | NOT COMPLETED | Radiofrequency Ablation First Than Varithena | 0 | |
| Part 2 | STARTED | Varithena® First Then Radiofrequency Ablation | 18 | |
| Part 2 | STARTED | Radiofrequency Ablation First Than Varithena | 17 | |
| Part 2 | COMPLETED | Varithena® First Then Radiofrequency Ablation | 17 | |
| Part 2 | COMPLETED | Radiofrequency Ablation First Than Varithena | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
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 | Pain in extremity | Musculoskeletal and connective tissue disorders | Varithena® | 1 | 34 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Radiofrequency Ablation | 2 | 34 | 2 |
| other | Phlebitis | Vascular disorders | Varithena® | 3 | 34 | 3 |
| other | Phlebitis | Vascular disorders | Radiofrequency Ablation | 1 | 34 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varithena® | 0 | 34 |
| Total, all-cause mortality | Radiofrequency Ablation | 0 | 34 |
| Total, other adverse events | Varithena® | 4 | 34 |
| Total, other adverse events | Radiofrequency Ablation | 3 | 34 |
| Total, serious adverse events | Varithena® | 0 | 34 |
| Total, serious adverse events | Radiofrequency Ablation | 0 | 34 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Varithena® vs Radiofrequency Ablation: Patient Preference | Trial comparisons |
| Varithena® vs Radiofrequency Ablation: deaths from any cause | Trial comparisons |
| Varithena® vs Radiofrequency Ablation: serious adverse events | Trial comparisons |
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/NCT02462720
GET https://conductscience.org/api/trials/v1/NCT02462720/registered