Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

July 22, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Radiation Proctopathy
Interventions
DEVICE

Purastat Arm

"Generic name of device and principal intended use(s):~Still PuraStat from a CE mark perspective. PuraStat is an aqueous self-assembling peptide solution of 2.5% concentration RADA16~Indication for use:~PuraStat is indicated for haemostasis in the following situations encountered during surgery, when haemostasis by ligation or standard means is insufficient or impractical:~* Bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs. Oozing from vascular anastomoses~* Bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures~* Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon."

DRUG

Standard Care Arm

Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term

Trial Locations (1)

M13 9WU

Manchester University NHS Foundation Trust, Manchester

All Listed Sponsors
collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

lead

Manchester University NHS Foundation Trust

OTHER_GOV

NCT04918758 - Endoscopically-delivered Purastat to Treat Bleeding Caused by Radiation Proctopathy | Biotech Hunter | Biotech Hunter