MedDataX Logo

Intra-Arterial Treatment of Pancreatic Cancer Using the RenovoCath™ RC120 Catheter

NCT ID: NCT02591082

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2021-02-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an observational, registry study to assess patient survival and clinical outcomes of the RenovoCath™ RC120 catheter when used to deliver chemotherapeutic agents to pancreatic tumors. Blood samples will be drawn in a subset of patients to assess the systemic concentration of the chemotherapeutic agent.

The RenovoCath™ RC120 Catheter is an endovascular multi-lumen, two-handled catheter designed to isolate variable segments of arteries supplying the target organ using two slideable, compliant balloons. Upon inflation of the proximal occlusion balloon and the distal occlusion balloon, the catheter may isolate the selected site to specifically deliver radiopaque and therapeutic agents including, but not limited to chemotherapeutic drugs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RenovoCath™ R120 Catheter

The RenovoCath™ RC120 Catheter will be used to isolate segments of arteries supplying blood to the pancreas. The two balloons on the catheter will be positioned and inflated to temporarily stop blood flow while medication is infused through the catheter between the balloons.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age
* Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology
* Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure
* Willing to provide informed consent and comply with the required follow-up.

Exclusion Criteria

* Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.
* Currently participating in another active drug or device study or registry protocol that would interfere with this study.
* Vulnerable populations: prisoners, pregnant or breastfeeding females.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenovoRx

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ramtin Agah, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Good Samaritan Hospital

San Jose, California, United States

Site Status

Fawcett Memorial Hospital

Port Charlotte, Florida, United States

Site Status

Florida Hospital

Tampa, Florida, United States

Site Status

Montefiore Hospital

The Bronx, New York, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Hatoum H, Rosemurgy A 2nd, Bastidas JA, Zervos E, Muscarella P 2nd, Edil BH, Cynamon J, Johnson DT, Thomas C, Swinson BM, Nordgren A, Vitulli P, Nutting C, Gipson M, Tsobanoudis A, Agah R. Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2. Oncologist. 2024 Aug 5;29(8):690-698. doi: 10.1093/oncolo/oyae178.

Reference Type DERIVED
PMID: 39049803 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RR2

Identifier Type: -

Identifier Source: org_study_id