Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis

NCT ID: NCT07026357

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2024-03-27

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Esophageal Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3D-planimetric Measurement

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

Group Type EXPERIMENTAL

3D-planimetric measurement

Intervention Type DEVICE

Esophageal stenosis is evaluated by 3D-planimetric measurement

Fluoroscopic control

Intervention Type RADIATION

Fluoroscopic control of dilatation therapy

Endoscopic control

Intervention Type DIAGNOSTIC_TEST

Macroscopic endoscopic control of dilatation therapy

Conventional Measurement

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

Group Type ACTIVE_COMPARATOR

Fluoroscopic control

Intervention Type RADIATION

Fluoroscopic control of dilatation therapy

Endoscopic control

Intervention Type DIAGNOSTIC_TEST

Macroscopic endoscopic control of dilatation therapy

Interventions

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3D-planimetric measurement

Esophageal stenosis is evaluated by 3D-planimetric measurement

Intervention Type DEVICE

Fluoroscopic control

Fluoroscopic control of dilatation therapy

Intervention Type RADIATION

Endoscopic control

Macroscopic endoscopic control of dilatation therapy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

University Hospital Augsburg

OTHER

Sponsor Role collaborator

University Hospital Munich

OTHER

Sponsor Role collaborator

Thomas Seufferlein

OTHER

Sponsor Role lead

Responsible Party

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Thomas Seufferlein

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Benjamin Walter, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

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University Hospital Ulm, Clinic for Internal Medicine I

Ulm, Baden-Wuerttenberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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UL001

Identifier Type: -

Identifier Source: org_study_id

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