An Prospective analysis on the clinical utility of 3D printing manufacturing patient-specific surgical guide with partial nephrectomy – a pilot study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0007068

Enrollment

Registered

2022-03-11

Start date

2021-09-08

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This kidney cancer partial resection surgical guide is a surgical aid for tumor precision resection by grafting only to the kidney surface during surgery, and is a customized surgical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Patients who have 18 years older b) Patients who diagnosed kidney cancer with primary tumor c) Patients who are scheduled to have partial nephrectomy d) Subjects who fully understands and agrees in writing to the infored consent form

Exclusion criteria

Exclusion criteria: a) Patients who have contraindications of MRI Those with an inserted electrical device, clip for the prevetion of aneurysm, aritificial of metalic material around the eyeball Patients who have Claustrophobia Patients who have contast allergic Pregnant b) Patients who have metastasis c) Patients who have multiple lesions d) Patients deemed unsuitable to participate in this clinical trial at the Investigator's discretion

Design outcomes

Primary

Measure	Time frame
margin positivity;Distance from tumor to edge of specimen	—

Secondary

Measure	Time frame
Volume of the removed specimen;surgery time;Warm/Cold Ischemia Time;Blood loss;Creatinine, eGFR;Complications;Ratio of transition to myopic resection or open surgery;Surgeon's satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Yoonsoo

Asan Medical Center

kyungys@amc.seoul.kr+82-2-3010-1550

Outcome results