Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry (IMPACT)
27. maj 2026 opdateret af: Lumicell, Inc.
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S. Food and Drug Administration (FDA) approved indication for use to collect data on the use of LumiSystem in a real-world setting to support the evaluation of safety, effectiveness, clinical utility (including impact to healthcare utilization and surgical management), and product and quality improvements.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
Lumicell Inc. has developed LumiSystem, a combination product consisting of LUMISIGHT (pegulicianine), an optical imaging agent, and Lumicell Direct Visualization System (DVS), a fluorescence imaging device.
U.S. Food and Drug Administration (FDA) approved this combination product on April 17, 2024, for the following indication for use: LUMISIGHT and Lumicell DVS are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
This registry study aims to enroll patients for whom LumiSystem has been clinically indicated and used commercially.
This protocol does not direct patient care.
This protocol directs the documentation of information about the care and procedures being provided to patients when using LumiSystem consistent with its approved labeling.
This registry study will collect data on the use of LumiSystem in a real-world setting.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
1500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: VP, Clinical Affairs and Pharmacovigilance
- Telefonnummer: 16174041033
- E-mail: kate@lumicell.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use
Beskrivelse
Inclusion Criteria:
- Participant must be consistent with FDA approved indication
Exclusion Criteria:
- Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Post market LumiSystem population consistent with FDA approved labeling
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients.
Tidsramme: Approximately 7 days
|
Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients.
|
Approximately 7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine change in margin status after using LumiSystem
Tidsramme: Up to approximately 6 weeks
|
Proportion of patients with at least one positive margin on the index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among all patients and Proportion of patients with at least one positive margin on index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among patients with at least one positive margin on standard lumpectomy.
|
Up to approximately 6 weeks
|
|
Determine impact to adjuvant radiotherapy treatment after using LumiSystem.
Tidsramme: Up to approximately 9 months
|
Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem.
|
Up to approximately 9 months
|
|
Determine impact to surgical intervention after using LumiSystem
Tidsramme: Up to approximately 6 weeks
|
Assess clinical utility of LumiSystem use.
|
Up to approximately 6 weeks
|
|
Compare LumiSystem performance against standard of care (SoC)
Tidsramme: Up to approximately 6 weeks
|
Proportion of LumiSystem-guided shaves that did not contain residual cancer taken after negative margins vs. proportion of standard of care (SoC) shaves that did not contain residual cancer taken after negative margins and proportion of LumiSystem-guided shaves taken after positive margins among positive margins vs. proportion of SoC shaves after positive margins among positive margins.
|
Up to approximately 6 weeks
|
|
Report on healthcare utilization for patients undergoing breast conserving surgery (BCS) with LumiSystem.
Tidsramme: Up to approximately 8 weeks
|
Change in healthcare utilization associated with use of LumiSystem
|
Up to approximately 8 weeks
|
|
Identification of safety signals.
Tidsramme: 7 days
|
Rate of adverse events and adverse device effects.
|
7 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. december 2030
Studieafslutning (Anslået)
1. december 2030
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
27. maj 2026
Først opslået (Faktiske)
1. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLP00205
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Two types of summary reports will be generated annually and shared with the site Investigators: i) one report will summarize the overall dataset ii) the second report will include the site's summary data from their own institute including benchmarks relative to the average without disclosure of the results of other institutions.
IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
IPD-delingsadgangskriterier
IPD from an institution will be shared with investigators from that institution who request this data for further analysis.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .