RecruitingPhase 3

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

United States198 participantsStarted 2023-12-01

Plain-language summary

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

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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:

✕. 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.
✕. 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 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.
✕. Suspected perforation of gastrointestinal tract

Treatment Success

Timeframe: 6 Months Post-Procedure

Primary Safety Outcome

Timeframe: 30 Days Post-Treatment

NCT IDNCT05561114

SponsorGIE Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Erika Wang

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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:

✕. 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.
✕. 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 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.
✕. Suspected perforation of gastrointestinal tract