Trial · NCT07907315
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Score at Tumescent Anesthesia Injection Completion (VAS-T2) | Measured immediately after TLA injection is completed and ultrasound confirms satisfactory perivenous fluid infiltration (before ablation begins) - Intraoperative (Day 0) | Pain intensity immediately after completion of tumescent local anesthesia (TLA) injection, assessed using the Visual Analog Scale (VAS). VAS is a clinical assessment tool that quantifies pain intensity using a linear scale approximately 10 centimeters long. The two ends of the scale are marked as "0" (no pain) and "10" (worst imaginable pain).The patient reports the most significant pain experienced during the entire TLA injection phase (from the first puncture to completion of injection). |
| Primary | Pain Score During Catheter Ablation (VAS-T3) | Measured immediately after completion of GSV trunk ablation and withdrawal of the ablation catheter | Pain intensity during the endovenous ablation phase, assessed using the Visual Analog Scale (VAS). The patient reports the most significant pain experienced during the entire ablation phase (from activation of the ablation device to completion of great saphenous vein trunk ablation).Visual Analog Scale (VAS): Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity). A score of 0 represents "no pain" and a score of 10 represents "worst imaginable pain." |
| Secondary | Intraoperative Pain Trajectory (Group × Time Interaction) | Assessed at four time points: T1 (immediately after sheath placement), T2 (immediately after TLA injection), T3 (immediately after ablation completion), and T4 (immediately after procedure completion) | Overall pattern of intraoperative pain across the four procedural time points, assessed to determine whether the pain trajectory differs between RFA and MWA groups. This is a composite measure derived by aggregating VAS scores from all four time points into a single repeated-measures model.VAS score (0-10 cm) analyzed as a repeated measure; reported as the group × time interaction effect (F-statistic and p-value) from a linear mixed effects model. VAS scores from T1, T2, T3, and T4 will be combined using a linear mixed effects model (LMM) with fixed effects for group, time, and group × time interaction, and random effects for individual patients. The reported value is the group × time interaction effect, which indicates whether the pain trajectory differs between groups. |
| Secondary | TLA Total Injection Volume | Recorded during the TLA injection phase | Total volume of tumescent local anesthesia (TLA) solution injected during the procedure.Milliliters (mL) |
| Secondary | RFA Ablation Energy Parameters | Intraoperative (Day 0); recorded during the ablation phase | Device-specific energy parameters for the RFA group, including temperature achieved.Temperature (°C) |
| Secondary | MWA Ablation Energy Parameters | Recorded during the ablation phase | Device-specific energy parameters for the MWA group, including power output .Power (Watts) |
| Secondary | Postoperative Pain at 2 Hours | Postoperative 2 hours | Pain intensity at rest in the treated leg at 2 hours after procedure completion.VAS score (0-10 cm) |
| Secondary | Postoperative Pain at 24 Hours | Postoperative 24 hours (Day 1) | Pain intensity at rest in the treated leg at 24 hours after procedure completion.VAS score (0-10 cm),Visual Analog Scale (VAS): Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity) |
| Secondary | Postoperative Pain at 7 Days | Postoperative 7 days (Day 7) | Pain intensity at rest in the treated leg at 7 days after procedure completion.VAS score (0-10 cm) |
| Secondary | Postoperative Pain at 30 Days | Postoperative 30 days (Day 30) | Pain intensity at rest in the treated leg at 30 days after procedure completion.VAS score (0-10 cm),VAS: Minimum = 0, Maximum = 10. Higher scores indicate worse outcome (greater pain intensity) |
| Secondary | Venous Clinical Severity Score (VCSS) at Baseline | Baseline (preoperative, within 7 days before surgery) | Disease-specific clinical severity assessed using the Venous Clinical Severity Score (VCSS) before treatment.VCSS score (0-30) |
| Secondary | Venous Clinical Severity Score (VCSS) at 30 Days | Postoperative 30 days (Day 30) | Disease-specific clinical severity assessed using the Venous Clinical Severity Score (VCSS) at 30 days after treatment.VCSS is a standardized tool for assessing the severity of lower extremity venous disease. It consists of 10 items (pain, varicose veins, edema, pigmentation, inflammation, induration, ulcer number/size/duration, and compression therapy). Each item is scored from 0 to 3, with a total score ranging from 0 to 30. Higher scores indicate more severe clinical symptoms. |
| Secondary | Change in Venous Clinical Severity Score (ΔVCSS) | Baseline to postoperative 30 days | Change in disease-specific clinical severity from baseline to 30 days after treatment. This is a derived composite measure calculated by subtracting the 30-day VCSS from the baseline VCSS.VCSS score change (baseline VCSS minus 30-day VCSS) |
| Secondary | Incidence of Adverse Events | Intraoperative through postoperative 30 days | Incidence and severity of all procedure-related adverse events from intraoperative period through 30 days post-procedure.Count and percentage of patients with ≥1 adverse event |
| Secondary | Factors Influencing Intraoperative Pain - Univariable Analysis | Intraoperative (Day 0); using data from all four time points (T1, T2, T3, T4) | Exploratory analysis to identify patient, anatomical, and procedural factors associated with pain at each intraoperative time point.Correlation coefficient (r or ρ) or regression coefficient (β) with 95% CI.Each candidate factor is tested individually against each VAS outcome (T1-T4). Results are reported as point estimates with 95% confidence intervals. |
| Secondary | Factors Influencing Intraoperative Pain - Multivariable Analysis | Intraoperative (Day 0); using data from T2 (TLA injection) and T3 (ablation) | Exploratory multivariable analysis to identify independent factors influencing pain at the two core time points (VAS-T2 and VAS-T3).Regression coefficient (β) with 95% CI.Separate multivariable linear regression models for VAS-T2 and VAS-T3. Each model includes group assignment, prespecified core variables, and univariable significant factors. |
| Secondary | Effect Modification by Patient/Procedural Factors (Group × Factor Interaction) | Intraoperative (Day 0); using data from T2 (TLA injection) and T3 (ablation) | Exploratory analysis to determine whether the effect of RFA vs. MWA on pain is modified by patient, anatomical, or procedural factors.Interaction effect (β for interaction term) with 95% CI and p-value.Each interaction term (group × factor) tested individually in separate regression models that include both main effects and the interaction. |
| Secondary | RFA Ablation Energy Parameters | Intraoperative (Day 0); recorded during the ablation phase | Device-specific energy parameters for the RFA group, including number of ablation segments and temperature achieved.Number of segments (count); temperature (°C) |
| Secondary | MWA Ablation Energy Parameters | Intraoperative (Day 0); recorded during the ablation phase | Device-specific energy parameters for the MWA group, including power output .Power (Watts) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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