Trial Outcomes & Findings for Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients (NCT NCT02296528)

Last Updated: 2026-04-20

Results Overview

UES opening will be measured via fluoroscopy. A digital still image will be captured at the point of maximum UES opening with and without anterior traction of the SED. The software will be calibrated to the known length of the SED that is visible in the fluoroscopic image. The distance between the anterior and posterior pharyngo-esophageal segment at the point of maximum UES opening will be measured. If swallowing is improved and there is no aspiration, the patient will be taught how to coordinate pulling the SED with the correct amount of force at the appropriate time during swallowing.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Before implantation, 2 months and 2 years post implantation

Results posted on

2026-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Swallowing Expansion Device Titanium swallowing expansion device Swallowing Expansion Device: SED looks like the letter "T" and has a plate and a post. The plate is like the top part of the "T" or smooth part of the tack. The plate is attached to the cartilage or flexible connective tissue of the throat. The SED post is like the bottom part of the "T" with a small ring. The post permanently sticks out from the throat, like a skin piercing. The SED is made out of titanium because this metal is extremely strong and commonly used in medical devices put into the body, such as hip joints or bone plates.
Overall Study STARTED	4
Overall Study Implantation of device	4
Overall Study Initiation of device use	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Swallowing Expansion Device n=4 Participants Titanium swallowing expansion device Swallowing Expansion Device: SED looks like the letter "T" and has a plate and a post. The plate is like the top part of the "T" or smooth part of the tack. The plate is attached to the cartilage or flexible connective tissue of the throat. The SED post is like the bottom part of the "T" with a small ring. The post permanently sticks out from the throat, like a skin piercing. The SED is made out of titanium because this metal is extremely strong and commonly used in medical devices put into the body, such as hip joints or bone plates.
Age, Categorical <=18 years	0 Participants n=129 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=129 Participants
Age, Categorical >=65 years	2 Participants n=129 Participants
Sex: Female, Male Female	0 Participants n=129 Participants
Sex: Female, Male Male	4 Participants n=129 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=129 Participants
Race (NIH/OMB) Asian	0 Participants n=129 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=129 Participants
Race (NIH/OMB) Black or African American	0 Participants n=129 Participants
Race (NIH/OMB) White	4 Participants n=129 Participants
Race (NIH/OMB) More than one race	0 Participants n=129 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=129 Participants
Region of Enrollment United States	1 participants n=129 Participants
Region of Enrollment New Zealand	3 participants n=129 Participants
UES Opening Pre Implant	0.24 mm STANDARD_DEVIATION .17 • n=129 Participants
Functional Oral Intake Pre Implant	1 score STANDARD_DEVIATION 0.0 • n=129 Participants

PRIMARY outcome

Timeframe: Before implantation, 2 months and 2 years post implantation

Outcome measures

Outcome measures
Measure	Swallowing Expansion Device n=4 Participants Titanium swallowing expansion device Swallowing Expansion Device: SED looks like the letter "T" and has a plate and a post. The plate is like the top part of the "T" or smooth part of the tack. The plate is attached to the cartilage or flexible connective tissue of the throat. The SED post is like the bottom part of the "T" with a small ring. The post permanently sticks out from the throat, like a skin piercing. The SED is made out of titanium because this metal is extremely strong and commonly used in medical devices put into the body, such as hip joints or bone plates.
Change in Upper Esophageal Sphincter (UES) Opening	.77 mm Standard Deviation .19

SECONDARY outcome

Timeframe: Before implantation, 2 months and 2 years post implantation

Population: All participants

A validated semi-quantitative scale to report functional oral intake. FOIS scale range (1-7) and indicating 1= no oral intake and 7= oral intake with no restrictions. Below is the detailed scale: 1. No oral intake 2. Tube dependence with minimal/inconsistent oral intake 3. Tube supplements with consistent oral intake 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. Total oral intake with no restrictions

Outcome measures

Outcome measures
Measure	Swallowing Expansion Device n=4 Participants Titanium swallowing expansion device Swallowing Expansion Device: SED looks like the letter "T" and has a plate and a post. The plate is like the top part of the "T" or smooth part of the tack. The plate is attached to the cartilage or flexible connective tissue of the throat. The SED post is like the bottom part of the "T" with a small ring. The post permanently sticks out from the throat, like a skin piercing. The SED is made out of titanium because this metal is extremely strong and commonly used in medical devices put into the body, such as hip joints or bone plates.
Change in Functional Oral Intake Scale	5 score Standard Deviation 0

Adverse Events

Swallowing Expansion Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Belafsky

UC Davis

Phone: 858.205.3366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place