To test if Nanosol device is efficient for peritoneal delivery of chemotherapy drugs

Estimating Efficiency Of Nanosol As A Drug Delivery System For Pressurized Intra-Peritoneal Aerosol Chemotherapy - NANOSOL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/12/030030

Enrollment

Registered

2020-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically verified peritoneal malignancy 2. No more than one extraperitoneal metastasis 3. Age >18 years 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones 2. A history of allergic reaction to platinum containing compounds or doxorubicin 3. Renal impairment , defined as glomerular filtration rate (GFR) 4. Impaired liver function defined as bilirubin >= 1.5 Ã? UNL (upper normal limit)

Design outcomes

Primary

Measure	Time frame
Depth of penetration and particle size estimation of the drugs produced using nanosol deviceTimepoint: follow-up at six monthly intervals post procedure	—

Secondary

Measure	Time frame
Survival and quality of life post treatment with PIPAC procedureTimepoint: follow-up at six monthly intervals post procedure	—

Countries

India

Contacts

Public ContactDr Swati Ahir Bist

ICMR-NIRRH

swatiahirbist@gmail.com9833750550

Outcome results