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

NCT02591082 | Completed

• 1 other identifier: RR2
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Survival

  Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas

  2 Years

Secondary Outcomes (1)

• Tumor response

  6 months

Interventions

RenovoCath™ R120 Catheter DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with unresectable or borderline resectable pancreatic cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenovoRx: lead

Study Sites (5)

Good Samaritan Hospital

San Jose, California, 95154, United States

Location

Fawcett Memorial Hospital

Port Charlotte, Florida, 33952, United States

Location

Florida Hospital

Tampa, Florida, 33613, United States

Location

Montefiore Hospital

The Bronx, New York, 10461, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (1)

• 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.

  PMID: 39049803 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ramtin Agah, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 29, 2015
• Study Start: December 1, 2015
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)