Severe stricture - dilation with 51-Fr for Swallowing Difficulty

Louisville VA Medical Center, Louisville, KY
Swallowing DifficultyNon severe stricture - dilation with 60-Fr - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is studying how well esophageal dilation works in patients with or without an esophageal stricture.

Eligible Conditions
  • Swallowing Difficulty

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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GIE Medical ProTractX3 TTS DCB
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Perivascular dexamethasone
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Group 2 - temsirolimus and dexamethasone injection

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

Month 12
Change in ability to tolerate diet in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by diet score.
Change in subjective symptoms of dysphagia in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by dysphagia score.
Month 12
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
Month 12
Achievement of complete relief of dysphagia
Dilation sessions required to achieved sustainable change in dysphagia and diet score
Year 1
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation
Month 12
Duration of sustained change between sessions

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

3
GIE Medical ProTractX3 TTS DCB
2
Perivascular dexamethasone
2
Group 2 - temsirolimus and dexamethasone injection

Trial Design

6 Treatment Groups

Severe stricture - dilation with 51-Fr
1 of 6
Without stricture - dilation with 60-Fr
1 of 6
Non severe stricture - dilation with 46-Fr
1 of 6
Non severe stricture - dilation with 60-Fr
1 of 6
Severe stricture - dilation with 42-Fr
1 of 6
Without stricture - dilation with 15-Fr
1 of 6

Active Control

Non-Treatment Group

168 Total Participants · 6 Treatment Groups

Primary Treatment: Severe stricture - dilation with 51-Fr · Has Placebo Group · N/A

Without stricture - dilation with 15-Fr
Procedure
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Procedure
Severe stricture - dilation with 51-Fr
Procedure
ActiveComparator Group · 1 Intervention: Severe stricture - dilation with 51-Fr · Intervention Types: Procedure
Without stricture - dilation with 60-Fr
Procedure
ActiveComparator Group · 1 Intervention: Dilation 60-Fr non stricture · Intervention Types: Procedure
Non severe stricture - dilation with 46-Fr
Procedure
ActiveComparator Group · 1 Intervention: Non severe stricture - dilation with 46-Fr · Intervention Types: Procedure
Non severe stricture - dilation with 60-Fr
Procedure
ActiveComparator Group · 1 Intervention: Non severe stricture - dilation with 60-Fr · Intervention Types: Procedure
Severe stricture - dilation with 42-Fr
Procedure
ActiveComparator Group · 1 Intervention: Severe stricture - dilation with 42-Fr · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months

Who is running the clinical trial?

University of LouisvilleLead Sponsor
322 Previous Clinical Trials
73,727 Total Patients Enrolled
Mohamed Eisa, MDPrincipal Investigator - University of Louisville School of Medicine
University of Louisville
Vincent Nguyen, MDPrincipal InvestigatorUniversity of Louisville School of Medicine
Endashaw Omer, MDStudy ChairUniversity of Louisville School of Medicine
Benjamin Rogers, MDStudy ChairUniversity of Louisville School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there still opportunities available to join this research project?

"Affirmative, the information published on clinicaltrials.gov attests to this medical experiment's ongoing recruitment process. The trial was inaugurated on March 24th 2021 and has been recently revised April 23rd 2022. 168 individuals are required between 3 distinct research sites." - Anonymous Online Contributor

Unverified Answer

How many participants are being offered participation in this research project?

"Affirmative. Per the information offered on clinicaltrials.gov, this medical trial is currently recruiting patients. The first posting was made on March 24th 2021 and the latest update happened April 23rd 2022. This study aims to find 168 participants from 3 different medical facilities." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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