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Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus (PATENT-E)

Primary Purpose

Esophageal Stricture

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GIE Medical ProTractX3 TTS DCB
Control
Sponsored by
GIE Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Stricture focused on measuring esophageal stricture, drug coated balloon, DCB, paclitaxel coated balloon

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 22 years
  2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations to at least 14mm within the last 12 months
  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, and purely radiation induced strictures (e.g. 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 throat 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 of 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 in the opinion of the investigator
  16. Acute stricture condition that requires emergent procedure (e.g. immediate dilation)
  17. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc
  18. Life expectancy of less than 24 months
  19. 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
  20. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint.
  21. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, hiatal hernia, etc.
  22. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy.
  23. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility.
  24. Intolerant to proton pump inhibitors
  25. Concurrent gastric and/or duodenal obstruction

Sites / Locations

  • Arkansas GastroenterologyRecruiting
  • New York Presbyterian Hospital- Columbia University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GIE Medical ProTractX3 TTS DCB

Control

Arm Description

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

Standard of Care Endoscopic Dilation

Outcomes

Primary Outcome Measures

Treatment Success
Ogilvie Dysphagia Score ≤1 without clinically driven repeat intervention
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)

Secondary Outcome Measures

Freedom from symptom recurrence
Symptom recurrence is defined as an Ogilvie Dysphagia Score of ≥2 or clinically driven reintervention.
Freedom from clinically driven reintervention
The rate of subjects free from clinically driven repeat intervention for the stricture treated at the index procedure in each arm will be assessed via Kaplan-Meier survival analysis.
Esophageal diameter ≥ 13mm
The proportion of subjects that successfully maintain an esophageal diameter ≥13mm through the 6 month visit, as measured by endoscopy.

Full Information

First Posted
September 27, 2022
Last Updated
September 5, 2023
Sponsor
GIE Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05561114
Brief Title
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Acronym
PATENT-E
Official Title
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
February 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GIE Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stricture
Keywords
esophageal stricture, drug coated balloon, DCB, paclitaxel coated balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GIE Medical ProTractX3 TTS DCB
Arm Type
Experimental
Arm Description
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard of Care Endoscopic Dilation
Intervention Type
Combination Product
Intervention Name(s)
GIE Medical ProTractX3 TTS DCB
Intervention Description
Paclitaxel Coated Balloon
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard Endoscopic Dilation
Primary Outcome Measure Information:
Title
Treatment Success
Description
Ogilvie Dysphagia Score ≤1 without clinically driven repeat intervention
Time Frame
6 Months Post-Treatment
Title
Primary Safety Outcome
Description
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-Treatment
Secondary Outcome Measure Information:
Title
Freedom from symptom recurrence
Description
Symptom recurrence is defined as an Ogilvie Dysphagia Score of ≥2 or clinically driven reintervention.
Time Frame
6 Months Post-Procedure
Title
Freedom from clinically driven reintervention
Description
The rate of subjects free from clinically driven repeat intervention for the stricture treated at the index procedure in each arm will be assessed via Kaplan-Meier survival analysis.
Time Frame
6 Months Post-Procedure
Title
Esophageal diameter ≥ 13mm
Description
The proportion of subjects that successfully maintain an esophageal diameter ≥13mm through the 6 month visit, as measured by endoscopy.
Time Frame
6 Months Post-Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 22 years Diagnosis of a benign esophageal stricture with at least 2 previous dilations to at least 14mm within the last 12 months Ogilvie Dysphagia Score of ≥2 Minimum esophageal lumen diameter <13 mm Willing and able to complete protocol required follow-up visits Willing and able to provide written informed consent Strictures ≤5cm in total length Target benign esophageal stricture etiologies include: Peptic stricture, Schatzki's ring, Stricture due to prior infection, Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy. Exclusion Criteria: 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, and purely radiation induced strictures (e.g. post head/neck cancer treatment). History of diagnosis of eosinophilic esophagitis (EoE) 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. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the throat 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. Suspected perforation of gastrointestinal tract Inability to pass guidewire across stricture Active systemic infection Allergy to paclitaxel of structurally related compounds Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use Received steroid injections into target stricture in the last 8 weeks. Stricture not amenable to endoscopic dilation in the opinion of the investigator Acute stricture condition that requires emergent procedure (e.g. immediate dilation) Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc Life expectancy of less than 24 months 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 Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, hiatal hernia, etc. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility. Intolerant to proton pump inhibitors Concurrent gastric and/or duodenal obstruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Wang
Phone
7633605659
Email
wange@giemedical.com
Facility Information:
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amie Crow
Email
amie@arkgi.net
Facility Name
New York Presbyterian Hospital- Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Musat
Phone
212-305-3009
Email
cm2065@cumc.columbia.edu

12. IPD Sharing Statement

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

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