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Search / Trial NCT06915662

Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 31, 2025

Trial Information

Current as of August 25, 2025

Not yet recruiting

Keywords

Tulavi Tulavi Allay Nerve Cap Neuroma Neuropathic Pain Digital Nerve Neuroma

ClinConnect Summary

This clinical trial is studying a new device called the Tulavi Allay™ Nerve Cap, which aims to prevent painful nerve growths (called neuromas) that can occur after a traumatic finger amputation. Neuromas can lead to ongoing pain and may require more surgeries, so finding effective ways to prevent them is very important for improving patients' quality of life. The trial will look at whether using this nerve cap can help reduce pain and other negative effects for people who have lost a finger due to injury.

To participate in this trial, patients must be 22 years or older and must have experienced a traumatic amputation of a single finger. They should also be able to speak English and be willing to take part in the study. Unfortunately, those who are pregnant or breastfeeding, or who are having a second surgery on the same finger, are not eligible. Participants will be closely monitored throughout the study to see how well the nerve cap works in preventing pain after their amputation. This trial is important because it could lead to better treatments and outcomes for many individuals facing similar challenges after finger amputations.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients undergoing traumatic amputation of a single digit at MGB
  • English-speaking
  • Exclusion Criteria:
  • Patients undergoing revision amputation or non-traumatic amputation Patients under 22 years old Patients who are pregnant and/or breastfeeding Unable or unwilling to participate in a trial study

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported