NCT05561114ClinicalTrials.gov

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

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To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Phase 3198 Teilnehmende gesucht34 Studienzentren1 Land

Kategorien

Gastroenterologie und Hepatologie100%

In 1 Register registriert

ClinicalTrials.govNCT05561114Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-09-30; recorded start 2023-12-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (GIE Medical)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding7/20
Single-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 34 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleSMALL

A small study: 198 participants (target), run at 34 sites.

How this score is built

Enrolment22/40
198 participants (target)
Site count18/25
34 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 89 months
Sponsor scale2/10
GIE Medical has led 4 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

Erkrankungen

Esophageal Stricture

Eignung

Eignung
Geschlecht	Alle
Alter	22 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: 1. Age ≥ 22 years 2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations 3. Ogilvie Dysphagia Score of ≥2 4. Minimum esophageal lumen diameter \<13 mm 5. Willing and able to complete protocol required follow-up visits 6. Willing and able to provide written informed consent 7. Strictures ≤5cm in total length 8. Target benign esophageal stricture etiologies include: 1. Peptic stricture, 2. Schatzki's ring, 3. Stricture due to prior infection, 4. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture 5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy Exclusion Criteria: 1. Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon. 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Contraindication to endoscopy, anesthesia or deep sedation 4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment. 5. History of diagnosis of eosinophilic esophagitis (EoE) 6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PET scan) and biopsy within 6 months of enrollment. 7. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment. 8. Suspected perforation of gastrointestinal tract 9. Inability to pass guidewire across stricture 10. Active systemic infection 11. Allergy to paclitaxel or structurally related compounds 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 14. Received steroid injections into target stricture in the last 8 weeks. 15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator 16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function. 17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation) 18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc 19. Life expectancy of less than 24 months 20. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc 21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint. 22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc. 23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy. 24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility. 25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists) 26. Concurrent gastric and/or duodenal obstruction

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	SINGLE (1)
Teilnahme	198 Teilnehmende gesucht

Sponsor und Mitwirkende

GIE Medical Sponsor

Studienarme und Interventionen

ControlACTIVE_COMPARATOR
Standard of Care Endoscopic Dilation
GIE Medical ProTractX3 TTS DCBEXPERIMENTAL
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Interventionen

Sonstige Control
Standard Endoscopic Dilation
Kombinationsprodukt GIE Medical ProTractX3 TTS DCB
Paclitaxel Coated Balloon

Endpunkte

Primärer Endpunkt
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
Zeitrahmen 6 Months Post-Procedure
Primärer Endpunkt
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Zeitrahmen 30 Days Post-Treatment
Sekundärer Endpunkt
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.
Zeitrahmen Annually
Sekundärer Endpunkt
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.
Zeitrahmen 6 Months Post-Procedure
Sekundärer Endpunkt
Clinical Responder Rate at 6 months
Zeitrahmen 6 Months Post-Procedure
Sekundärer Endpunkt
Freedom from clinically driven target stricture reintervention through 6 months post-procedure
Zeitrahmen 6 Months Post-Procedure
Sekundärer Endpunkt
Freedom from symptom recurrence through 6 months post-procedure
Zeitrahmen 6 Months Post-Procedure
Sonstiger Endpunkt
Secondary Patency
Zeitrahmen Time between the index procedure to the second clinically driven intervention
Sonstiger Endpunkt
Technical Success
Zeitrahmen Procedure
Sonstiger Endpunkt
Annualized rate of dilations before and after treatment
Zeitrahmen Annually
Sonstiger Endpunkt
Improvement in time between dilations
Zeitrahmen Between Dilations
Sonstiger Endpunkt
Improvement in Ogilvie Dysphagia Score at each follow-up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Improvement in Dysphagia Handicap Index score at each follow-up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Stricture characteristics per functional imaging
Zeitrahmen Between Dilations
Sonstiger Endpunkt
Number of esophageal dilation procedures through each follow up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Freedom from clinically driven reintervention through each follow-up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Freedom from symptom recurrence through each follow-up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
VAS for pain scores through 30-day follow-up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Composite EQ-5D quality of life scores at each follow-up
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

Daten

Daten
Startdatum	1. Dezember 2023 (tatsächlich)
Primärer Abschluss	1. Oktober 2026 (geschätzt)
Abschluss	1. April 2031 (geschätzt)
Erstveröffentlichung	30. September 2022 (tatsächlich)
Zuletzt aktualisiert	25. Juni 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

33 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
University of Colorado Anschutz	Aurora	Colorado	Rekrutiert
Birmingham Gastroenterology Associates	Birmingham	Alabama	Rekrutierung noch nicht begonnen
Brigham and Women's Hospital	Boston	Massachusetts	Rekrutiert
University of North Carolina Chapel Hill	Chapel Hill	North Carolina	Rekrutiert
Rush University	Chicago	Illinois	Rekrutiert
University of Florida	Gainesville	Florida	Rekrutiert
Baylor St. Luke's Medical Center	Houston	Texas	Rekrutiert
University of California, Irvine	Irvine	California	Rekrutiert
Borland-Groover	Jacksonville	Florida	Rekrutiert
Gastro Care Institute	Lancaster	California	Rekrutiert
Sierra Clinical Research	Las Vegas	Nevada	Rekrutiert
Cedars Sinai	Los Angeles	California	Rekrutiert
University of Louisville	Louisville	Kentucky	Rekrutiert
Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia	Rekrutiert
Tandem Clinical Research	Marrero	Louisiana	Rekrutiert
Research Associates of South Florida	Miami	Florida	Rekrutiert
West Virginia University	Morgantown	West Virginia	Rekrutiert
Vanderbilt University Medical Center	Nashville	Tennessee	Rekrutiert
New York Presbyterian Hospital- Columbia University Medical Center	New York	New York	Rekrutiert
Hillcrest Medical Research	Orange City	Florida	Rekrutiert
Orlando Health	Orlando	Florida	Rekrutiert
University of Pennsylvania	Philadelphia	Pennsylvania	Rekrutiert
Thomas Jefferson University	Philadelphia	Pennsylvania	Rekrutiert
Einstein Medical Center	Philadelphia	Pennsylvania	Rekrutiert
Rutgers University	Piscataway	New Jersey	Rekrutiert
Allegheny Health Network	Pittsburgh	Pennsylvania	Rekrutiert
TEN20 Clinical Research	Plano	Texas	Rekrutiert
Oregon Health and Science University	Portland	Oregon	Rekrutiert
The University of Utah	Salt Lake City	Utah	Rekrutiert
San Diego Gastroenterology	San Diego	California	Rekrutiert
Honor Health	Scottsdale	Arizona	Rekrutiert
Swedish Medical Center	Seattle	Washington	Rekrutiert
Washington University	St Louis	Missouri	Rekrutiert
Kansas Gastroenterology, LLC	Wichita	Kansas	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT05561114