Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
ConditionEsophageal Stricture
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorGIE Medical
About this trial
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 22 years
Diagnosis of a benign esophageal stricture with at least 2 previous dilations
Ogilvie Dysphagia Score of ≥2
Minimum esophageal lumen diameter <13 mm
Disqualifiers
Two or more clinically significant (e.g. non-traversable) strictures with total length >5cm or unable to be treated with a single balloon.
Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months
Contraindication to endoscopy, anesthesia or deep sedation
Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
GIE Medical ProTractX3 TTS DCB
Combination productPaclitaxel Coated Balloon
Control
Other interventionStandard Endoscopic Dilation
Treatment groups
198 Participants
are divided into 2 treatment groupsGroup A: GIE Medical ProTractX3 TTS DCBExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Success
1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee
Time frame
6 Months Post-Procedure2
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Time frame
30 Days Post-TreatmentSecondary outcomes
1
Annualized Rate of Reintervention
The annualized reintervention rate is defined as the annualized number of clinically driven interventions and will be assessed by comparing the annualized rate per patient year between groups using a test of Poisson rates.
Time frame
Annually2
Diameter Improvement at 6 months
The minimum esophageal stricture diameter will be assessed by a functional luminal imaging probe (EndoFLIP) during endoscopy and compared between the Test and Control arms. The minimum esophageal stricture diameter will be measured at baseline and during the 6-month follow-up, or at the time of a reintervention if one occurs prior to 6 months.
Time frame
6 Months Post-Procedure3
Clinical Responder Rate at 6 months
Time frame
6 Months Post-Procedure4
Freedom from clinically driven target stricture reintervention through 6 months post-procedure
Time frame
6 Months Post-ProcedureOther outcomes
1
Secondary Patency
Time frame
Time between the index procedure to the second clinically driven intervention2
Technical Success
Time frame
Procedure3
Annualized rate of dilations before and after treatment
Time frame
Annually4
Improvement in time between dilations
Time frame
Between DilationsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov