NCT01337206

Brief Summary

The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2.5 years

First QC Date

April 13, 2011

Last Update Submit

February 5, 2015

Conditions

Benign Esophageal Lesions

Keywords

Esophageal StenosisEsopageal StricturesEsophageal Dysphagia

Outcome Measures

Primary Outcomes (1)

  • The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent

    3 - 6 months

Secondary Outcomes (9)

  • Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion

    6 - 12 months

  • Time to recurrent significant dysphagia

    6 - 12 months

  • Time to dilation of recurrent stricture

    6 - 12 months

  • 6 months and 12 months incidence of repeat dilation

    6 - 12 months

  • Serious and minor adverse events with possible or likely relation to the study Intervention

    6 - 12 months

  • +4 more secondary outcomes

Study Arms (2)

Stenting Arm

EXPERIMENTAL

Stenting Arm

Device: Stenting with ELLA Biodegradable stent

Dilation Arm

ACTIVE COMPARATOR

Dilation Arm

Procedure: Standard Dilations

Interventions

Stenting with ELLA Biodegradable stentDEVICE

Treating benign esophageal lesions with the placement of a degradable stent

Also known as: Esophageal Stenting
Stenting Arm
Standard DilationsPROCEDURE

Treating benign esophageal lesions with standard dilation therapy

Also known as: Bougie Dilation, Balloon Dilation
Dilation Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)

You may not qualify if:

  • Patient \< 18 years old
  • Patient is unwilling or unable to sign and date the informed consent
  • Patient is unwilling or unable to comply with the follow-up schedule
  • Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months
  • Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
  • Patient with a life expectancy \< 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinique Universitaire Saint Luc

Brussels, 1000, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

IRCCS Istituto Clinico Humanitas

Milan, 20089, Italy

Location

Academic Medical Center

Amsterdam, 22700, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

University Medical Center Utrech

Utrecht, 3508, Netherlands

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

Location

University College of London Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

  • Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8.

    PMID: 29883979DERIVED

MeSH Terms

Conditions

Esophageal StenosisDeglutition Disorders

Interventions

Stents

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Peter D. Siersema, MD, PhD

    University Medical Center Utrech

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 18, 2011

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

January 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

NL(3)GB(1)BE(2)ES(1)IT(1)