Participant flow

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery · Source last updated 2025-05-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   This group of the study will receive 100mg of Bevonescein (ALM-488). Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue. 100mg of ALM-488 will be intravenously infused.

   id

   FG000

   title

   Dose Defining Cohort 100mg

2. description

   This group of the study will receive 200mg of ALM-488. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue. 200mg of ALM-488 will be intravenously infused.

   id

   FG001

   title

   Dose Defining Cohort 200mg

3. description

   This group of the study will receive 400mg of Bevonescein (ALM-488). Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue. 400mg of ALM-488 will be intravenously infused.

   id

   FG002

   title

   Dose Defining Cohort 400mg

4. description

   This group of the study will receive 500mg of Bevonescein (ALM-488). Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue. 500mg of ALM-488 will be intravenously infused.

   id

   FG003

   title

   Dose Defining Cohort 500mg

5. description

   This group of the study will receive 600mg of Bevonescein (ALM-488). Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue. 600mg of ALM-488 will be intravenously infused.

   id

   FG004

   title

   Dose Defining Cohort 600mg

6. description

   This arm of the study will include patients infused wtih Bevonescein (ALM-488) at 500mg 3-5 hours prior to skin incision. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

   id

   FG005

   title

   Dose Timing Cohort 3-5 Hours

7. description

   This arm of the study will include patients infused wtih Bevonescein (ALM-488) at 500mg 1-3 hours prior to skin incision. Bevonescein (ALM-488): ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

   id

   FG006

   title

   Dose Timing Cohort 1-3 Hours

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      COVID-19 related hospitalization

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         6

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice