NCT04221867

Brief Summary

In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Status
unknown

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

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

January 6, 2020

Last Update Submit

February 28, 2021

Conditions

Esophageal StrictureFat Graft

Keywords

Esophageal StrictureFat GraftDilation

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events at 3 months

    Types, severity and probability of procedure related adverse events

    3 months

  • Incidence of Treatment-Emergent Adverse Events at 12 months

    Types, severity and probability of procedure related adverse events

    12 months

Secondary Outcomes (6)

  • Change from Baseline Eckardt score at 3 months

    3 months

  • Change from Baseline Eckardt-score at 12 months

    12 months

  • Change from Baseline Stricture Lumen diameter at 3 months

    3 months

  • Change from Baseline Stricture Lumen diameter at 12 months

    12 months

  • Change from Baseline Stricture length at 3 months

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Esophageal stricture patients

EXPERIMENTAL

Patients suffering from benign esophageal stricture are treated with through-the scope CRE dilation balloon. Free fat graft is gathered from the abdominal subcutaneous fat. Fat graft is prepared and injected to the stricture site.

Procedure: Stricture dilation with CRE balloonProcedure: Autologous fat grafting

Interventions

Stricture dilation with CRE balloonPROCEDURE

Esophageal stricture is treated by dilation therapy.

Esophageal stricture patients
Autologous fat graftingPROCEDURE

Autologous fat graft is gathered and injected to stricture

Esophageal stricture patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Esophageal stricture that has re-occurred at least once

You may not qualify if:

  • Malignant etiology of esophageal stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal StenosisDilatation, Pathologic

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Pauliina Hartiala, Surgeon

    Turku University Hospital

    STUDY DIRECTOR

Central Study Contacts

Hannes A Kortekangas, Surgeon

CONTACT

+35823139192hannes.kortekangas@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastrointestinal surgeon / Consultant in Division of Gastrointestinal Surgery

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

August 15, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

March 2, 2021

Record last verified: 2021-02