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NCT04007692 Clinical Trial

Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation

Suture, Complication Clinical Trial

Official title:
Suturing Pattern for Endolumenal Stenting Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04007692
Other study ID # 18-003817
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 15, 2019
Est. completion date July 2024

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.

Description:

The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects aged 18 or above - Subjects undergoing esophageal stent placement with any indication Exclusion Criteria: - Imprisoned individuals, - Institutionalized patients - Inability or unwillingness of individual

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stent migration rate Number of participants with stent migration as assessed by objective evidence of stent migration on endoscopy at 3-4 weeks after esophageal stent placement 4 weeks post stent placement
Primary Adverse Events Number of adverse events reported 4 weeks
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