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NCT04787939 · ClinicalTrials.gov registry record · NA

Early Feeding After Oral Cavity Reconstruction

A NA study of Head and Neck Cancer and Free Tissue Transfer, sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
NA
Development phase
89
Enrollment target
1
Study location

NCT04787939 is a NA study of Head and Neck Cancer and Free Tissue Transfer that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 89 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04787939, a NA study of Head and Neck Cancer and Free Tissue Transfer, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
NA
Development phase
89 participants
Enrollment target
1
Study location

Study Summary

This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately after surgery to those rates published in the literature (individuals for whom oral feeding is delayed for several days after surgery). Eighty nine subjects who will undergo oral cavity reconstructive surgery will be enrolled between Mount Sinai Hospital and Mount Sinai West. Study participation will last for 30 days after surgery during which time patients will be examined for any signs or symptoms of surgical site infection or wound breakdown, have several clinical evaluations of swallow function, and be asked to report on several patient reported outcome measures.

Interventions

  • BEHAVIORAL Early Feeding

Study Locations (1)

New York

  • Mount Sinai Health System - New York

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2021-03-10
Est. Completion 2025-12
Phase NA

What the Registry Record Tells You About NCT04787939

The ClinicalTrials.gov registry entry for NCT04787939 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (66% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Early Feeding is the first listed.

NCT04787939 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04787939 about?

NCT04787939 is a clinical study titled "Early Feeding After Oral Cavity Reconstruction". This is a prospective single-arm non-inferiority trial evaluating surgical outcomes in subjects who are fed in the first days after oral cavity reconstructive surgery. The purpose of the study is to specifically compare the rates of orocutaneous fistula in subjects who are allowed to eat immediately...

What is the current status of trial NCT04787939?

This trial is currently recruiting. It is a NA study. The enrollment target is 89 participants. The study started on 2021-03-10. Estimated completion is 2025-12.

What conditions does trial NCT04787939 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Free Tissue Transfer.

What interventions are being tested in trial NCT04787939?

The interventions under investigation include: Early Feeding (BEHAVIORAL).

Who is sponsoring clinical trial NCT04787939?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04787939 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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