Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.

NCT02862288 | Completed Phase 1

• 1 other identifier: API/2011/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.

Conditions

Lung Tumor; Bone Tumor; Renal Tumor

Outcome Measures

Primary Outcomes (1)

• Tumor necrosis rate in post-intervention over one month monitoring period.

  one month

Study Arms (3)

Renal tumor

EXPERIMENTAL

Microwave ablation of renal tumor

Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Lung tumor

EXPERIMENTAL

Microwave ablation of lung tumor

Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Bone tumor

EXPERIMENTAL

Microwave ablation of bone tumor

Device: Microwave ablation with Acculis Accu2i pMTA Applicator

Interventions

Microwave ablation with Acculis Accu2i pMTA Applicator DEVICE

Bone tumor; Lung tumor; Renal tumor

Eligibility Criteria

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

You may qualify if:

• Men and women \> 18 years old
• Thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - Generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia
• Signature of informed consent for participation
• Affiliation to a social security scheme or French beneficiary of such a regime.

You may not qualify if:

• Contraindication to percutaneous thermoablation
• Renal or lung tumor up to 4 cm
• Women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception
• Legal incapacity or legal capacity limited
• Person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator
• Person without health insurance
• Pregnant women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Bone Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bone Diseases; Musculoskeletal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Sébastien Aubry, M.D.

  Centre hospitalier régional universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: September 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 11, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)