This study is not yet accepting patients

REVIVE Prospective Registry Cohort Study

a study on Deglutition Disorders Oropharyngeal Dysphagia Head and Neck Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Clark Rosen, MD
Headshot of Clark Rosen
Clark Rosen

Description

Summary

The main purpose of this registry is to collect observational, long-term safety and effectiveness data in participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study.

Official Title

Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of REVIVE Clinical Study in Patients With Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer

Details

This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person. The objectives of this study are to:

  • Evaluate the long-term safety of iltamiocel
  • Evaluate the long-term effectiveness of iltamiocel treatment as demonstrated through anterior tongue strength and patient reported outcomes (PROs) related to tongue dysphagia (TD) symptoms, quality of life (QOL), and overall satisfaction.

The duration of participants' participation in this registry will extend to 5 years after enrollment. This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person.

Keywords

Oropharyngeal Dysphagia, Tongue, Dysphagia, Autologous, Deglutition Disorders, Tongue Dysphagia Oropharyngeal Cancer

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants who have received iltamiocel as part of participation in the REVIVE clinical study for males and females with tongue dysphagia (TD) are eligible, provided the following criteria are fulfilled:
    • Has completed the Month 24 visit in the REVIVE study.
    • Has received iltamiocel as part of the blinded portion of the REVIVE study.
    • Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.

You CAN'T join if...

  • The following criteria will exclude participants from participation:
    • Has received placebo as part of the blinded portion of the REVIVE study.
    • Unable or unwilling to provide informed consent.
    • Not available for, or willing to comply with the follow-up evaluations as required by the protocol.

Locations

  • UC SanFrancisco Medical Center
    San Francisco California 94115 United States
  • UC Davis Medical Center
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • Clark Rosen, MD
    Clark Rosen, MD is a Director of the UCSF Voice and Swallowing Center, Chief of the Division of Laryngology, Professor of Otolaryngology-Head and Neck Surgery. Dr. Rosen is originally from Los Gatos, California and is a proud graduate of Cal (Go Bears!).

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Peter Belafsky, MD
ID
NCT07429890
Study Type
Observational [Patient Registry]
Participants
Expecting 31 study participants
Last Updated