MediView Launches Multicenter Study for XR90 Surgical Navigation System in Soft Tissue Biopsy

Analysis reveals significant industry trends and economic implications

Release Date

2025-07-09

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

MediView has initiated a multicenter clinical study to evaluate the XR90 Holographic Surgical Navigation system's effectiveness in percutaneous soft tissue tumor biopsies. The study, involving 104 patients across multiple healthcare institutions, will assess the system's procedural efficiency when used alongside standard imaging techniques like ultrasound and CT. The primary objective is to compare the efficiency of XR90-assisted procedures against standard-of-care imaging alone. The FDA-cleared XR90 system aims to improve clinician workflow and patient care by providing intuitive 3D visualization and remote collaboration capabilities.

Key Highlights

  • First patient enrolled in a multicenter clinical study evaluating MediView's XR90 Surgical Navigation system for soft tissue biopsy.
  • The study will enroll 104 patients over 24 months across multiple leading healthcare institutions.
  • The primary objective is to assess the procedural efficiency of XR90 compared to standard-of-care imaging alone.
  • The XR90 system is FDA-cleared (K223125) and aims to improve clinician workflow and patient care.

Study Design Parameters

Soft Tissue Tumor Biopsy Study Designs and Endpoints

Study Designs

  • Retrospective analyses were common across multiple studies examining biopsy techniques
  • Diagnostic accuracy studies were conducted to assess performance of various biopsy methods
  • Cohort studies with consecutive patients were used to evaluate biopsy efficacy
  • Comparative studies between different biopsy techniques (e.g., ultrasound-guided core needle biopsy vs fine-needle aspiration)
  • Image-guided biopsies were evaluated using CT guidance, ultrasound guidance, and PET/CT guidance

Patient Populations

  • Studies included patients with various conditions requiring biopsy:

  • Breast cancer patients (428 patients in one study, 88 women in another)

  • Thyroid nodule patients (350 consecutive patients with 461 nodules)

  • Lymphoma suspects (99 procedures)

  • Lung cancer suspects (353 patients)

  • Adrenal neoplasm patients (163 biopsies on 154 patients)

  • Uveal melanoma patients (105 primary tumors)

Biopsy Techniques

  • Sentinel lymph node biopsy (SLNB) with radioisotope tracers (99mTc-albumin nanocolloid)
  • Ultrasound-guided core needle biopsy (UG-CNB) compared to ultrasound-guided fine-needle aspiration (UG-FNA)
  • CT-guided core needle biopsy for lung lesions
  • PET/CT-guided needle biopsy for lymphoma
  • Percutaneous adrenal biopsy for adrenal masses

Primary Endpoints

  • Diagnostic accuracy (98.5% for CT-guided lung biopsies)
  • Diagnostic yield (87.5% for PET-guided lymphoma biopsies)
  • Sensitivity and specificity (96% sensitivity, 100% specificity for PET-guided lymphoma biopsies)
  • Positive and negative predictive values (100% PPV, 75% NPV for lymphoma biopsies)
  • Adequacy of sampling (UG-CNB: 98% adequate vs UG-FNA: 73% adequate)
  • Histopathological diagnosis rates (99.3% of NSCLC cases diagnosed with specific subtypes)
  • Molecular testing success rates (98.7% conclusive EGFR mutation results)

Secondary Endpoints

  • Procedure time (median 20 minutes for CT-guided lung biopsies)
  • Complication rates (minimal across studies)

  • Ability to obtain sufficient tissue for:

  • Molecular testing (EGFR mutations, EML4-ALK rearrangements)

  • Clinical trial screening (93.8% fulfilled pathological evaluation requirements)

  • Biobanking (99.4% provided extra tissue)

  • Correlation with final surgical pathology (89-94% accuracy for thyroid nodule malignancy)

Safety Outcomes

  • Procedure-related complications were minimal across studies
  • Pain during procedures (3% of PET-guided biopsies interrupted due to pain)
  • No serious adverse events reported in most studies

Incidence and Prevalence

Global Epidemiology of Soft Tissue Tumor Biopsies

Incidence and Prevalence Data

Based on available data, a study conducted at Swami Ramanand Teerth Rural Government Medical College in India (2015-2017) identified 200 soft tissue neoplasm cases out of 4,494 neoplasms, accounting for 4.45% of all neoplasms. Of these 200 cases:

  • 94% (188 cases) were benign
  • 6% (12 cases) were malignant

The study found that benign neoplasms were most common in individuals aged 21-40 years with a slight male predominance. Regarding anatomical distribution:

  • Upper extremity was the most frequent site for benign soft tissue tumors
  • Followed by the trunk, head and neck, and lower extremity
  • Malignant soft tissue neoplasms were most commonly found in the lower extremity

Histological Distribution

Among the 200 soft tissue neoplasms identified in the Indian study:

  • Adipocytic tumors were most prevalent (105 cases, 52.5%)
  • Vascular neoplasms (32 cases, 16%)
  • Peripheral nerve sheath tumors (22 cases, 11%)

For specific rare subtypes such as PEComa (perivascular epithelioid cell tumor), a type of mesenchymal tumor, the incidence is <1 per 1,000,000 people. The most frequent sites of PEComas are the uterus and retroperitoneum.

Regional and Demographic Variations

The available information does not contain specific data about global statistics on soft tissue neoplasm sampling procedures that vary by geographical region, demographic factors, and histological subtypes based on latest systematic reviews and meta-analyses.

XR90 Holographic Surgical Navigation System Clinical Trials

Based on the provided context, there is no information available about the XR90 Holographic Surgical Navigation system or any clinical trials related to it. The context does not contain any data regarding:

  • Clinical indications being investigated for the XR90 system
  • Surgical intervention methodologies or procedural models used in trials
  • Patient inclusion criteria or outcome measures for any applications of the XR90 system

Without specific information in the provided context, I cannot provide details about indications beyond soft tissue tumor biopsy, intervention models, or other aspects of clinical trials for this system.