Changeflow GovPing Pharma & Healthcare ACSS Surgical Approaches and Dysphagia Comparis...
Routine Notice Added Final

ACSS Surgical Approaches and Dysphagia Comparison Study

Favicon for changeflow.com ClinicalTrials.gov Studies
Detected
Email

Summary

NIH registered an observational clinical study (NCT07533864) comparing two anterior cervical spine surgery (ACSS) approaches—Smith-Robinson versus strap-splitting—for their effects on dysphagia (swallowing difficulties) and voice changes. The study will enroll participants assigned to either approach based on surgeon preference, with follow-up questionnaires assessing swallowing and speaking outcomes. This registry entry documents an active clinical investigation on a common spinal procedure with known swallowing-related complications.

Published by NIH on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

NIH registered a new observational study (NCT07533864) on ClinicalTrials.gov comparing two anterior cervical spine surgery approaches—Smith-Robinson and strap-splitting—for their impact on postoperative dysphagia, hoarseness, and swallowing pain. Participants undergo one approach based on surgeon preference and complete follow-up questionnaires assessing speech and swallowing function.

For healthcare providers and spinal surgeons, this study adds to the evidence base on surgical technique selection and complication profiles. The findings may inform future clinical practice guidelines on approach selection for anterior cervical procedures. Medical device manufacturers whose products are used in these procedures have no immediate compliance obligations but should monitor emerging outcomes data that may influence surgical technique preferences.

Archived snapshot

Apr 16, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

ACSS Approach on Dysphagia

Observational NCT07533864 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

Anterior cervical spine surgery (ACSS) is a procedure for the treatment of several neck problems. Even though the procedure is overall safe and effective, there are possible complications after surgery, which include problems swallowing, hoarseness of the voice, and pain when swallowing.

There are two different ways the spinal surgeon can approach the spine from the front of the neck. One is called a Smith-Robinson approach, and the other is called a strap-splitting approach. Each approach uses the same skin cut, the difference is only in how the next layer is approached, whether on the outside (Smith-Robinson) or through (strap-splitting) one of the small muscles in your neck. Because of the slightly different approaches to the surgery, we want to see if there are differences in complications related to swallowing and speaking between these two approaches.

Participants will undergo one of the two surgical approaches, based on surgeon preference. Participants will complete a questionnaire at several time points during their clinical follow-up to assess any difficulties swallowing and speaking.

Conditions: Anterior Cervical Spine Surgery

View original document →

Get daily alerts for ClinicalTrials.gov Studies

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from NIH.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533864
Docket
NCT07533864

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical research Medical procedure assessment Surgical technique evaluation
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Clinical Research

Get alerts for this source

We'll email you when ClinicalTrials.gov Studies publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!