Home
Clinical Trials
Paclitaxel Coated Balloon for...

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

Last Updated: 2025-06-25

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2031-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus

NCT03097666

Barrett Esophagus

COMPLETED NA

Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®

NCT06024525

Coronary Artery Disease

NOT_YET_RECRUITING NA

Paclitaxel Eluting Balloon Catheter in Coronary De-novo Lesions Treatment in China

NCT03466749

Coronary Disease

UNKNOWN NA

Paclitaxel Eluting Balloon for SFA In-stent Restenosis

NCT01616888

In-stent Arterial Restenosis

UNKNOWN NA

Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula

NCT02753998

Angioplasty Stenosis of Arteriovenous Fistula

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Stricture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GIE Medical ProTractX3 TTS DCB

The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

Group Type EXPERIMENTAL

GIE Medical ProTractX3 TTS DCB

Intervention Type COMBINATION_PRODUCT

Paclitaxel Coated Balloon

Control

Standard of Care Endoscopic Dilation

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Standard Endoscopic Dilation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GIE Medical ProTractX3 TTS DCB

Paclitaxel Coated Balloon

Intervention Type COMBINATION_PRODUCT

Control

Standard Endoscopic Dilation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers