MedTrace Logo

Intraoperative Radiation Therapy for Locally Advanced or Recurrent Abdomino-pelvic Solid Tumors With the CivaSheet

NCT02902107 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-10-21

No results posted yet for this study

Summary

This study is a pilot study of the CivaSheet, a new type of intraoperative radiation therapy (IORT) device that offers several advantages over existing techniques of performing IORT. The CivaSheet device in this study is already approved by the FDA and is not an experimental device. This study will allow us to determine how feasible it is to implant the CivaSheet into patients undergoing surgery for abdominal and pelvic tumors, and assess any possible side effects of the device. This study, if successful, may allow us to offer the CivaSheet more widely as treatment option to future patients.

Conditions

  • Abdominal Malignancy
  • Pelvic Malignancy

Interventions

DEVICE

CivaSheet

RADIATION

Brachytherapy

PROCEDURE

surgical resection

Sponsors & Collaborators

Principal Investigators

  • Abraham Wu, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-09
Primary Completion
2024-10-17
Completion
2024-10-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902107 on ClinicalTrials.gov