A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

Flowonix Medical

Status: Withdrawn

Conditions: Cancer Pain; Pain Management

Treatments: Device: Intrathecal Drug Delivery System; Other: Conventional Medical Management

Study type: Interventional

Funder types: Industry

Identifiers

NCT02578459

PM-02

Details and patient eligibility

About

The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.

Full description

This study is a non-randomized, open-label, single-center study that will compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from pancreatic cancer pain.

There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain. Systemic analgesics will not be prescribed for this group. Control group (CMM): These subjects will be treated with CMM to treat their pain.

A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this study at one study center.

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has Stage IV pancreatic cancer.
2. Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
3. Patient agrees not to obtain pain medications from other physicians during the study.
4. Patient is at least 22 years of age.
5. Investigator considers the patient to be able and willing to fulfill all study requirements.
6. Patient is able to understand the study and provide written informed consent to participate in the study.

Exclusion criteria

1. Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
2. Patient is enrolled in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intrathecal Drug Delivery (ITDD)

Experimental group

Description:

These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.

Treatment:

Device: Intrathecal Drug Delivery System

Conventional Medical Management (CMM)

Active Comparator group

Description:

These subjects will be treated with conventional medical management to treat their pain.

Treatment:

Other: Conventional Medical Management