NCT03349021

Brief Summary

Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 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

November 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

5 months

First QC Date

November 14, 2017

Last Update Submit

October 16, 2018

Conditions

Esophagostenosis

Keywords

esophagusstenosisbougienage

Outcome Measures

Primary Outcomes (1)

  • Efficient bougienage with BougieCap

    To measure the effect of bougienage a passage with the endoscope should be possible.after Treatment with the BougieCap (5mm Endoscope, 10mm endoscope)

    Day 0 (directly) after endoscopy

Secondary Outcomes (1)

  • Qol dysphagia

    Day 0 before endoscopy and Day14 after treatment

Study Arms (1)

Bougiecap

EXPERIMENTAL

Treatment with Bougiecap instead of Savary Bougie

Device: Bougiecap

Interventions

BougiecapDEVICE

Treatment of esophagel Stenosis by Bougiecap

Bougiecap

Eligibility Criteria

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

You may qualify if:

  • benign Stenosis of the esophagus
  • indication for endoscopic treamtent of stenosis

You may not qualify if:

  • no informed consent
  • malignancy based Stenosis
  • no indication for endoscopic treamtent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitätklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Marienhospital

Essen, Germany

Location

Southhamptan University Hospital

Southhampton, United Kingdom

Location

Related Publications (1)

  • Walter B, Schmidbaur S, Rahman I, Albers D, Schumacher B, Meining A. The BougieCap - a new method for endoscopic treatment of complex benign esophageal stenosis: results from a multicenter study. Endoscopy. 2019 Sep;51(9):866-870. doi: 10.1055/a-0959-1535. Epub 2019 Jul 23.

    PMID: 31342473DERIVED

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Meining, Prof.

    Head of Endoscopy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Endoscopy

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 21, 2017

Study Start

February 1, 2018

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)DE(2)