Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

CellFX System

Richard A. Nuccitelli, PhD

This prospective, multicenter, study is designed to evaluate the safety and effectiveness of the CellFX System in adults subjects with low-risk basal cell carcinoma (superficial and nodular) for complete histological clearance of the target lesion followed by surgical tumor excision 60 days post-treatment.

The study will enroll healthy adult subjects with confirmed low-risk (superficial and nodular) BCC lesion(s) by biopsy, excluding BCCs located on the face, neck, scalp, axilla, hands, feet, and genitals not exceeding 1.5 cm. Macrophotography of all study BCCs will be captured and clinically assessed by the site investigator for characterization of healing and scar appearance prior to and post-surgical excision. All subjects will be followed at 3, 7, 14, 30 and 60-days post-CellFX procedure and at 14, 30 and 60-days post-excision. Adverse events will be documented.

CellFX Treat & Resect Low-Risk BCC Feasibility Study

A Multicenter, Prospective, Treat and Resect Feasibility Study of the CellFX System for the Treatment of Low-Risk Basal Cell Carcinoma (BCC) Lesions

The primary effectiveness endpoint is the total number of lesions with complete histological clearance of the BCC lesion during histological review of microscopic analysis using H \& E slides. Counts and proportions will be assessed.

No serious adverse events related to CellFX Treatment or Procedure

Pulse Biosciences, Inc.

Treatment of the BCC with CellFX System

CellFX System: Nano-Pulse Stimulation (NPS)

CellFX Procedure

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Histological presence of superficial or nodular BCC

The total number of enrolled subjects in this study was 30 participants with 37 lesions.

William Knape / VP, Clinical, Regulatory and Quality Affairs

Number of Lesions With BCC Histological Clearance

Number of Participants With Treatment Related Serious Adverse Events

Overall Study

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

With institutional review board approval from Zagazig University Hospitals 338. A double-centre prospective study was conducted on prospectively collected data of all morbidly. 17 patients in Zagazig University Hospitals, Faculty of Medicine, Egypt and 321 patients done in bariatric surgery excellence unit in a tertiary hospital in Riyadh-KSA.

Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm

Laparoscopic sleeve gastrectomy

Bassem M Sieda

LSG is thought to be the best choice for obese patients with conincidental GISTs, as a tumour can be resected along with resecting the stomach within the same procedure. The primary endpoint is that, how much does GIST suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

The incidence of unsuspected GIST in LSG specimens in our series was high in comparison to cases reported in the literature.

GISTs could be safely removed laparoscopically during LSG surgery with negative microscopic resection margins, with 1-2cm safety margin. Margins less than 1cm, high mitotic rate are adverse prognostic factors.

Examining the whole stomach before resection is mandatory and can easily be done during LSG, GIST can be removed safely with LSG

Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

WHEN REGISTERED AND APPROVED FOR PUBLICATION, I WILL SHARE THROUGH ALL SCIENTIFIC SITES

we analyzed the incidence of GISTs in patients underwent LSG and investigated whether simultaneous resection can be oncologically adequate. as long as GIST is distal to staple line with a negative margin, laparoscopic sleeve gastrectomy can be done safely.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CellFX Treat & Resect Low-Risk BCC Feasibility Study	NCT04918381	BCC - Basal Cel... BCC Excision Margin	CellFX System	22 Years - 85 Years	Pulse Biosciences, Inc.
Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin	NCT04344847	Excision Margin	Laparoscopic sl...	21 Years - 42 Years	Zagazig University
CellFX Treat & Resect Low-Risk BCC Feasibility Study	NCT04918381	BCC - Basal Cel... BCC Excision Margin	CellFX System	22 Years - 85 Years	Pulse Biosciences, Inc.

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