NCT07026357

Brief Summary

Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health. For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines. Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult. Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

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

June 7, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 7, 2022

Last Update Submit

June 15, 2025

Conditions

Benign Esophageal Stricture

Outcome Measures

Primary Outcomes (1)

  • Endoscopic therapy success

    Change in esophageal diameter \[mm\] and length of esophageal stricture \[cm\] after endoscopic therapy

    3 months after intervention at endoscopic control examination

Secondary Outcomes (9)

  • Length measurement of esophageal stenosis

    during endoscopic intervention

  • Postinterventional esophageal diameter

    directly after endoscopic intervention

  • Hospitalization time after endoscopic dilatation therapy

    within 3 months after study intervention

  • Number of endoscopic interventions

    within 3 months after study intervention

  • Number of hospitalizations due to complications

    within 3 months after initial study intervention

  • +4 more secondary outcomes

Study Arms (2)

3D-planimetric Measurement

EXPERIMENTAL

Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)

Device: 3D-planimetric measurementRadiation: Fluoroscopic controlDiagnostic Test: Endoscopic control

Conventional Measurement

ACTIVE COMPARATOR

Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only

Radiation: Fluoroscopic controlDiagnostic Test: Endoscopic control

Interventions

3D-planimetric measurementDEVICE

Esophageal stenosis is evaluated by 3D-planimetric measurement

3D-planimetric Measurement
Fluoroscopic controlRADIATION

Fluoroscopic control of dilatation therapy

3D-planimetric MeasurementConventional Measurement
Endoscopic controlDIAGNOSTIC_TEST

Macroscopic endoscopic control of dilatation therapy

3D-planimetric MeasurementConventional Measurement

Eligibility Criteria

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

You may qualify if:

  • symptomatic benign esophageal stenosis
  • medical indication for endoscopic therapy
  • written consent after detailed information

You may not qualify if:

  • non-benign esophageal stenosis
  • missing written consent
  • trans-oral endoscopic access is not possible
  • medical contraindication for endoscopic dilatation therapy
  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ulm, Clinic for Internal Medicine I

Ulm, Baden-Wuerttenberg, 89081, Germany

Location

Study Officials

  • Benjamin Walter, PhD

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 18, 2025

Study Start

December 28, 2022

Primary Completion

March 27, 2024

Study Completion

March 27, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)