Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-04 @ 4:03 PM
Study NCT ID:
NCT07026292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-18
First Post:
2025-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLVA-PULL
Brief Summary:
Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TZ3582023-013 | OTHER_GRANT | Tianjin Medical University Cancer Institute and Hospital | View |