MarginProbe 2.0 Data Collection Protocol

• Sponsor: Dilon Medical Technologies Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05377229
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Anticipated Duration (Months): 24.5
• Patients Per Site: 500
• Patients Per Site Per Month: 20.4

Study Details

Study Description

Brief Summary

Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system.

In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: MarginProbe2.0

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: MarginProbe 2.0 Data Collection Protocol
• Actual Study Start Date: Dec 15, 2021
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Adverse Events (AEs) and Serious Adverse Events (SAEs) [During the lumpectomy surgery]

   Adverse Events (AEs) and Serious Adverse Events (SAEs)

2. Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure. [During the lumpectomy surgery]

   The cohorts will continue to be collected until a final algorithm is established and the cohort(s) can be collected with the final algorithm to determine the sensitivity and specificity to demonstrate non-inferiority to the MP1.x system.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women over 18 years of age

2. Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure

3. Signed Informed Consent Form

Exclusion Criteria:

1. Undergoing re-excision procedure

2. Concurrent infectious disease

3. Pregnancy

4. Lactation

5. Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast

6. Prior radiation treatment in the operated breast

7. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
2	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

• Dilon Medical Technologies Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dilon Medical Technologies Ltd.
• ClinicalTrials.gov Identifier: NCT05377229
• Other Study ID Numbers: CP-13-001
• First Posted: May 17, 2022
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Dilon Medical Technologies Ltd.: MarginProbe; Breast Cancer; Lumpectomy
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of May 17, 2022